Final Program

ENAR

2015SPRING MEETING With IMS & Sections of ASA MARCH 15 –18 Hyatt Regency Miami Miami, FL FINAL PROGRAM

4 Welcome and Overview 6 Acknowledgements 13 Special Thanks 15 Miami Highlights 18 Presidential Invited Speaker 19 IMS Medallion Lecture 20 Short Courses 23 Tutorials 26 Roundtables 29 Program Summary 44 Scientific Program 148 Index 161 Floor Plan WELCOME

¡Bienvenidos a Miami! It is my great pleasure to introduce the 2015 ENAR Spring Meeting to be held at the Hyatt Regency Miami, in Miami, FL, from March 15-18. The ENAR Spring Meeting brings together researchers and practitioners from academia, industry and government, connected through a common interest in Biom- etry. It offers a unique opportunity for learning new exciting methods and software, hearing about interesting and impactful applications, meeting new people (including prospective employers and job candidates), reconnecting with friends, and, this year, getting a break from the cold and snowy winter. The ENAR Spring Meeting only hap- pens through the diligent work of a large number of people who organize and contribute to the program, plan and oversee the meeting logistics, and help with sponsorship – my heartfelt gratitude to all of them.

Scientific Program: Through the leadership of Program Chair Mithat Gönen, of Memorial Sloan- Kettering Cancer Center, and Associate Chair Brisa Sánchez, of the University of Michigan School of Public Health, and with contributions from many of you, the Program Committee (with representatives from different ASA sections) has created an outstanding invited program. The sessions cover a wide range of topics of great interest to both researchers and practitioners, such as, data sciences (big data), genomics, clinical trials, neuroimaging, biomarkers, health policy, electronic health records, ecology, and epidemiology. The IMS invited program, assembled under the leadership of IMS Program Chair Lurdes Inoue, of the University of Washington, also features an exciting array of sessions that nicely complement and promote synergies with the ENAR invited program.

Poster presentations will, once again, be a vibrant part of the scientific program. In addition to contributed and invited posters (the latter first featured in the 2014 meeting), the 2015 ENAR Spring Meeting introduces a novelty: Contributed oral poster sessions, in which presenters will be able to give a two-minute elevator-speech on the highlights of their posters. The contributed oral sessions, to be held on Monday, will be organized by themes, will feature two invited posters from well-known researchers, and will run parallel to the rest of the sessions in the scientific program. As in previous years, the regular contributed and invited posters will be presented Sunday evening, during the Opening Mixer. The highly popular ENAR Regional Advisory Board (RAB) poster competition will include contributed posters from the Sunday session only.

Educational Program: Be sure to take advantage of the unique and varied learning opportunities that the 2015 ENAR Spring Meeting has to offer through its superb program of short courses, tutorials and roundtables, assembled by the Educational Advisory Committee. Presented by well-known experts in their respective fields, the short courses and tutorials will cover a variety of topics of great interest to meeting attendees, including: Bayesian methods in drug development, personalized medicine trial designs, analysis of brain imaging data, data sciences and high performance statistical computing, early phase clinical trials, statistical leadership and influence, graphics for clinical trial data, and software applications for group sequential and adaptive designs, Bayesian modeling and analysis, and multiplicity problems. A favorite of many who come to the meeting, roundtable luncheons will also be featured in the program. Distinguished statisticians from academia, government, and industry will lead the luncheon discussions on topics ranging from how to publish without perishing to innovations in drug development to Bayesian evidence synthesis.

Keynote Lectures: The Presidential Invited Address and the IMS Medallion Lecture are two of the high points of the ENAR Spring Meeting program, delivered by highly accomplished thought leaders in Biom- etry. I am honored to introduce Dr. David L. DeMets, Max Halperin Professor of Biostatistics and former Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin – Madi-

4 ENAR 2015 | Spring Meeting | March 15–18 son, as the 2015 Presidential Invited Speaker. His lecture will be on “Big Data, Big Opportunities, Big Challenges.” Prof. DeMets has been an inspirational role model for more than a generation of biostatisticians working in clinical research across academia, government, and industry. His pioneering and highly impactful research in group sequential designs during his tenure at the National Heart, Lung and Blood Institute, at NIH, the creation of the Department of Biostatistics at the University of Wisconsin, and his seminal work in establishing statistical leadership in drug regulatory sciences and practice (including, literally, writing the book on Data Monitoring Committees), are just a few of his many achievements. He is a past-president of ENAR and the Society for Clini- cal Trials, as well as an Elected Fellow of the International Statistics Institute, the American Statistical Association, the Association for the Advancement of Science, the Society for Clinical Trials and the American Medical Informatics Association. In 2013, he was elected as a member of the Institute of Medicine.

The IMS Medallion Lecture, entitled “Uncertainty Quantification in Complex Simulation Models Using Ensemble Copula Cou- pling,” will be presented by Dr. Tilmann Gneiting, Group Leader at the Heidelberg Institute for Theoretical Studies (HITS) and Profes- sor of Computational Statistics at the Karlsruhe Institute of Technology (KIT) in Germany. Prof. Gneiting has held faculty positions in the Department of Statistics at the University of Washington, where he remains affiliate faculty, and at the Institute for Applied Mathematics at Heidelberg University. He serves as Editor for Physical Science, Computing, Engineering, and the Environment at the Annals of Applied Statistics.

Additional Meeting Activities: The 2015 ENAR Spring Meeting will feature a host of other activities in addition to the scientific and educational programs. On Saturday, March 14, there will be the Junior Researchers Workshop, organized under the leadership of Kimberly Drews, George Washington, University. The Fostering Diversity in Biostatistics Workshop, organized by Simone Gray, of the Centers for Disease Prevention and Control, and Sean Simpson, of Wake Forest School of Medicine, will be held on Sunday,

The Student Mixer on Monday evening and the Tuesday luncheon event organized by the Council of Emerging and New Statisti- cians (CENS) will provide ample networking opportunities for students and recent graduates. Meeting attendees seeking employ- ment and prospective employers will benefit from the vibrant Career Placement Center. Be sure to visit the exhibitors’ area to browse the latest books and software in your field.

A perennial favorite among many attendees, the Tuesday night social event for the 2015 meeting will take place at sea: a dinner cruise aboard the Biscayne Lady yacht. We will be picked up by boat at the Riverwalk in front of the hotel and will enjoy a memo- rable evening of breathtaking views of the Miami skyline, great food, nice conversation, music and dancing. Boat cruises have sold out quickly in previous ENAR meetings held in Florida, so sound statistical inference suggests that you should get your tickets early.

Meeting Venue: The conference will be held at the Hyatt Miami Regency hotel located by the Miami Riverwalk, in the downtown area. The hotel is within walking distance from the bustling Mary Brickell district, with its shops, restaurants, and nightlife. South Beach, showcasing beautiful Art Deco architecture, is a short cab drive away and so is Calle Ocho, in the heart of Little Havana.

Acknowledgements: This meeting would not happen without the dedication and leadership of Kathy Hoskins, the ENAR Executive Director. Kathy is the institutional memory of ENAR and each year patiently guides incoming presidents-elect, like myself, on the how-to’s of organizing the Spring Meeting. My heartfelt thanks to Kathy and the ENAR team, Challee Blackwelder and Katie Earley, for all the great work they have put into the meeting organization.

I am also very grateful to the Local Arrangements Committee, led (for a second time) by Tulay Koru-Sengul, of the University of Miami Miller School of Medicine, for their critical work towards the success of the ENAR meeting.

Welcome to the 2015 ENAR Spring Meeting!

Sincerely,

José Pinheiro Kathy Hoskins 2015 ENAR President ENAR Executive Director

Program 5 ENAR 2015 ACKNOWLEDGEMENTS

ENAR would like to Acknowledge the Generous Support of the 2015 Local Arrangements Committee, chaired by Tulay Koru-Sengul, University of Miami, and our Student Volunteers.

We Gratefully Acknowledge NIH, We Gratefully Acknowledge the and in Particular the: Invaluable Support and Generosity National Cancer Institute of Our Sponsors and Exhibitors. National Heart, Lung, & Blood Sponsors Institute AbbVie National Institute of Environmental Alexion Health Sciences Biogen Idec Inc. National Institute of Allergy and Infectious Diseases Cytel Inc. For their Generous Support of the Eli Lilly and Company ENAR Junior Researchers Workshop JANSSEN Pharmaceutical Companies of Johnson & Johnson ENAR Junior Researchers’ Novartis Oncology Workshop Coalition Members Parexel Columbia University The Proctor & Gamble Co. Emory University Quintiles – Center for Statistics ENAR in Drug Development Harvard University SAS Institute Inc. The Johns Hopkins University Statistics Collaborative, Inc. North Carolina State University Statistics in Medicine/Wiley The University of Michigan Exhibitors The University of Minnesota Cambridge University Press The University of North Carolina at Chapel Hill CRC Press The University of Pennsylvania Minitab The University of Pittsburgh Oxford University Press The University of Wisconsin- SAS Institute Inc. Madison Springer Virginia Commonwealth University Texas A&M University – Department of Statistics Wiley

Regional Committee (RECOM) President | Chair | José Pinheiro Eight Ordinary Members (elected to 3-year terms): + Philip Reiss (RAB Chair)

2013-2015 2014-2016 2015-2017 Sudipto Banerjee Michael Daniels Paul Albert Jeffrey Morris Michelle Dunn Reneé Moore Dionne Price Xihong Lin Mary Sammel

Regional Members of the International Biometric Society | Executive Board Karen Bandeen-Roche Joel Greenhouse Sharon-Lise Normand José Pinheiro

Regional Members of the Council of the International Biometric Society Scarlett Bellamy Brad Carlin Timothy Johnson KyungMann Kim

Appointed Members of Regional Advisory Board (3-year terms) Chair | Philip Reiss 2013-2015 2014-2016 2015-2017 Richard Cook Hongyua Cao Sean Devlin Lynn Eberly Susmita Datta Susan Halabi Zhezhen Jin Martin Lindquist Telba Irony Clara Kim Qi Long Sheng Lou Mi-Ok Kim Brian Millen Olga Marchenko Monnie McGee Alison Motsinger-Reif David Ohlssen Peter Thall Todd Ogden Limin Peng Sharon Xie Sean Simpson Elena Polverejan Elizabeth Zell Abdus Wahed Arindam RoyChoudhury Menggang Yu Ronglai Shen Programs

2015 Spring Meeting | Miami, FL Program Chair | Mithat Gönen

Associate Chair | Brisa Sánchez ENAR Local Arrangements | Tulay Koru-Sengul

2015SPRING MEETING

2016 Spring Meeting | Austin, TX ENAR Program Chair | Wei Sun Spring Meeting Associate Chair | Laura Hatfield 2016 Local Arrangements | Mike Daniels With IMS & Sections of ASA s

Joint Statistical Meetings | 2015 | Olga Marchenko | 2016 | Bin Nan

Biometrics Executive Editor | Marie Davidian Visit the ENAR Biometrics Co-Editors | Jeanine Houwing-Duistermaat website Yi-Hau Chen Michael Daniels www.enar.org Biometric Bulletin Editor | Dimitris Karlis as a resource for JABES Editor | Monteserrat Fuentes all ENAR activities. ENAR Correspondent for the Biometric Bulletin | Leslie McClure ENAR Executive Director | Kathy Hoskins

International Biometric Society Executive Director | Dee Ann Walker Programs Representatives

ENAR Standing/Continuing Committees

Nominating Committee (2015) Chair | DuBois Bowman 2016 Spring Meeting | Austin, TX Members | Dan Heitjan (2015) Maura Stokes (2014-2015) Program Chair | Wei Sun Stacy Lindborg (2014-2015) Associate Chair | Laura Hatfield Sponsorship Committee (2015) Local Arrangements | Mike Daniels Diane Catellier Rhonda Szczesniak Bo Yang Névine Zariffa

Webinar Committee (2015) Chair | Lynn Eberly Mi-Ok Kim Philip Reiss Peter Thall

ENAR Representative on the ASA Committee on Meetings Laura Meyerson Joint Statistical Meetings | 2015 | Olga Marchenko | 2016 | Bin Nan

Distinguished Student Paper Awards Committee Chair | Daniel Heitjan, Southern Methodist University Veera Baladandayuthapani, MD Anderson Cancer Center Veronica Berrocal, University of Michigan Min Chen, University of Texas, Dallas Jason Fine, University of North Carolina - Chapel Hill Debashis Ghosh, Penn State University Joseph Hogan, Brown University Mingyao Li, University of Pennsylvania Martin Lindquist, Johns Hopkins Bloomberg School of Public Health Brian Neelon, Duke University Michael Newton, University of Wisconsin Brian Reich, North Carolina State University Taki Shinohara, University of Pennsylvania

Program 9 Alisa Stephens, University of Pennsylvania Matthew White, Children’s Hospital Boston Julian Wolfson, University of Minnesota Gui-Shuang Ying, University of Pennsylvania

Van Ryzin Award Winner Jean-Philippe Fortin, Johns Hopkins University Bloomberg School of Public Health

Distinguished Student Paper Award Winners Joseph Antonelli, Harvard School of Public Health Guanhua Chen, Vanderbilt University and University of North Carolina, Chapel Hill Chuan Hong, The University of Texas School of Public Health Peijie Hou, University of South Carolina Yue Hu, Rice University Lei Huang, Johns Hopkins University Runchao Jiang, North Carolina State University Edward Kennedy, University of Pennsylvania SungHwan Kim, University of Pittsburgh Eunjee Lee, University of North Carolina Ying Liu, Columbia University Xiaoye Ma, University of Minnesota Lu Mao, University of North Carolina, Chapel Hill Christine Mauro, Columbia University Peibei Shi, University of Illinois, Urbana-Champaign Thomas Stewart, University of North Carolina Yichi Zhang, North Carolina State University Yi Zhao, Brown University Yan Zhou, University of Michigan

2015 Fostering Diversity in Biostatistics Workshop Co-Chair | Simone Gray, Centers for Disease Control Co-Chair | Sean Simpson, Wake Forest School of Medicine Knashawn H. Morales, University of Pennsylvania, Perelman School of Medicine Scarlett Bellamy, University of Pennsylvania, Perelman School of Medicine DuBois Bowman, Columbia University, Mailman School of Public Health Amita Manatunga, Emory University, Rollins School of Public Health Reneé H. Moore, North Carolina State University Sastry Pantula, North Carolina State University Adriana Perez, The University of Texas Health Science Center at Houston Dionne Price, Food and Drug Administration DeJuran Richardson, Lake Forest College Louise Ryan, University of Technology Sydney Keith Soper, Merck Research Laboratories Alisa J. Stephens, University of Pennsylvania, Perelman School of Medicine Lance Waller, Emory University, Rollins School of Public Health

10 ENAR 2015 | Spring Meeting | March 15–18 2015 RAB Poster Award Competition Committee Chair | Philip Reiss, New York University Maitreyee Bose, University of Minnesota Erica Dawson, University of Alabama at Birmingham Dominque Williams, Eli Lilly Pei-Shien Wu, New York University Yuting Xu, Johns Hopkins University

2015 Council for Emerging and New Statisticians (CENS) RAB Liaisons | Chair | Clara Kim Elizabeth Zell Brian Millen Philip Reiss Members | Jarcy Zee Victoria Liublinska Tapan Mehta Naomi Brownstein Vivian Shih Diana Hall Michael McIsaac Erica Billig Chanmin Kim Jami Jackson Kaitlin Woo

National Institute of Statistical Sciences | Board of Trustees (The ENAR President is also an ex-officio member) Member | Donna Brogan

Program 11 ENAR

2015SPRING MEETING

12 ENAR 2015 | Spring Meeting | March 15–18 ENAR 2015

SPECIAL THANKS Feng Dai Program Committee Yale University Program Chair ASA Statistical Education Mithat Gönen Section Memorial Sloan-Kettering Edward Boone Cancer Center Virginia Commonwealth University Program Co-Chair ASA Statistics and the Brisa N. Sánchez Environment Section University of Michigan Madhu Mazumdar IMS Program Chair Mt. Sinai School of Medicine ASA Statistics in Epidemiology Lurdes Inoue Section University of Washington Haipeng Shen University of North Carolina at Chapel Hill ASA Statistics in Imaging ASA Section Section Representatives TingTing Zhang Li Hong Qi University of Virginia University of California at Davis ASA Statistical Learning ASA Biometrics Section and Data Mining Section

Gary Aras Rebecca Andridge Amgen Ohio State University ASA Biopharmaceutical ASA Survey Research Methods Section Section

Nick Horton Nancy Petersen Amherst College US Department of Veterans ASA Mental Health Section Affairs Laura Freeman ASA Statistical Programmers Institute for Defense Analysis Section ASA Statistics in Defense and National Security Section

Program 13 ENAR Student Awards 2015 Daniel F. Heitjan Chair University of Pennsylvania ENAR Diversity 2015 ENAR Program Committee Workshop 2015 Simone Gray ENAR At-large Local Arrangements Co-Chair Members Chair Centers for Disease Rima Izem Tulay Koru-Sengul Control and Prevention Food and Drug Administration University of Miami Sean L. Simpson Yevgen Tymofyeyev Education Advisory Co-Chair Johnson & Johnson Committee Wake Forest School of Medicine Ronglai Shen José Pinheiro Memorial Sloan-Kettering 2015 ENAR President ENAR Workshop for Cancer Center Johnson & Johnson Junior Biostatisticians Laura White Rick Chappell in Health Research Boston University University of Wisconsin, Kimberly Drews Madison George Washington University Advising Members Telba Irony ENAR Executive Team José Pinheiro Food and Drug Administration 2015 ENAR President Kathy Hoskins Johnson & Johnson Dionne Price Executive Director Food and Drug Administration Rick Chappell Katie Earley University of Wisconsin, Bhramar Mukherjee Program Manager Madison University of Michigan Challee Blackwelder Gordon Lan Administrator Johnson & Johnson

14 ENAR 2015 | Spring Meeting | March 15–18 MIAMI HIGHLIGHTS MIAMI Welcome to Miami! Miami is a global metropolis with booming international business, vibrant culture, and some of the best beaches in the world.

Much of Miami’s appeal is due to its diverse neighborhoods, which range from the towering skyscrapers of downtown Miami to the Cuban community of Little Havana or to the trendy Miami Beach neighborhood of South Beach. People from all over the world come to enjoy the sunny weather, spicy nightlife and fine dining!

Miami has a cuisine that is uniquely its own. With the diversity of its people comes a blend of flavors – Latin, Caribbean and US – known as Floribean. Miami also has outstanding restaurants of every kind, from Italian to Thai. If you’re feeling barbeque, try a nostalgic and delicious landmark next door to Datran Center Skyscrapers, Shorty’s Bar-B-Q. When touring South Beach, take a rest and people-watch for a while at the News Café while enjoying their twenty-four hour breakfast and decadent desserts. If you’re willing to wait (no reservations!), satisfy your seafood desire by going to Joe’s Stone Crab, a restaurant famous for stone crab claws and claims to be the place where this tasty treat was first discovered. Can’t decide? Then take a Miami Culinary Tour – a Miami food tour adventure tasting delicious foods around the city’s historic neighborhoods. Program 15 No matter what kind of entertainment grabs your interest, Miami has it covered. Fulfill your desire for cultural programs at the Adrienne Arsht Center for the Performing Arts; Broadway shows, dance pro- ductions and concerts are on the schedule at this beautiful facility located less than two miles from the Hyatt Regency Miami. Head across the Bay to South Beach to experience the Art Deco District, where the largest collection of Art Deco architecture in the world can be found. Experience a different kind of pool at Coral Gables Venetian Pool, the only swim- ming pool on the National Register of Historic Places that’s chlorine-free and fed with cool spring water.

Of course, there is always the beach – take an afternoon and find a spot along Miami’s gorgeous shoreline and soak up the sun!

Blessed with a warm climate and unrivaled Brickell ocean access, America’s southernmost resort Miami’s financial district, just south of Down- city is also a sought-after international rec- town, offers some of the best nightlife and reation destination. Miami caters to action- dining the city has to offer. Visit some of the oriented visitors from around the globe with neighborhood’s best restaurants like Per- some of the world’s top golf, tennis and sport- ricone’s, Brickell Burger and Beer, and La ing facilities. Add sparkling waters that are a Lupita. See the high rises and condo com- magnet for boating enthusiasts, fishermen, plexes of Miami’s young professionals or divers and water sports aficionados to the check out Blue Martini or Fado Irish Pub for equation and it is easy to see why Miami is a drinks and dancing. You don’t want to miss number one choice for active travelers of all the ‘Manhattan of the South’. ages and skill levels. So to really experience South Florida, you must get out on the water! Bayside Market Rent a boat, see manatees in the wild at Coral Experience the best food, fun, and shopping Gables, swim with dolphins, or take a windsurf- Miami has to offer! You will certainly enjoy ing lesson — it’s all here! the open-air feeling of this Miami shopping mall, a short walk or Metromover ride from the Hyatt, with over 150 stores while walking

16 under the palm trees. One of Vizcaya Museum Coral Castle the most interesting features of this Downtown Miami loca- And Gardens Museum tion is probably the Biscayne Vizcaya is one of South Located near Homestead, Bay and Miami Skyline view Florida’s leading attractions. the castle is comprised of you will get, so even if your Built by agricultural industrial- numerous coral stones, each purpose is not to spend a big ist James Deering, Vizcaya weighing several tons. Many amount of money, go by and Museum & Gardens features of the castle structures are check it out. It’s also ideal for a main house, ten acres of notable, including machines finding boat tour operators, formal gardens, a rockland to tell time, home-made air enjoying live night entertain- hammock (native forest), and conditioners, and a nine-ton ment, and taking tours to soon-to-be-restored historic revolving door. To this day, Miami’s celebrities’ homes. village. Its art and furnishings no one knows how Edward portray 400 years of Euro- Leedskalnin created the Coral Jungle Queen pean history and provide a Castle. Built under the cover of Riverboat Cruise window to both the history night and in secret, at a time For more than 50 years, of Miami, graced by the villa when there were no modern visitors have traveled on this since its completion in 1916; construction conveniences, Ed stately river- and to the Italian Renais- would only say that he knew boat. Tours sance, represented in the “the secret of the pyramids.” sail past Museum’s architecture. First, Visit this site and try to figure estates while you’ll pass through Vizcaya’s out the mystery. an entertain- lush subtropical forest and Everglades ing mono- approach the Main House logue by along a walkway lined with National Park the captain fountains and foliage. The This national park protects points out the inside of the house is filled the southern 25 percent of homes of the with treasures from around the original everglades and famous and the world. Hear Vizcaya’s has a subtropical climate, a the infamous. 1917 pipe organ played Mon- broad, shallow river, and a On three-hour day through Friday from 12 variety of plant and animal life day tours or four-hour din- noon to 12:30 pm. Outside, that makes this a must visit. ner voyages you can sail to you’ll enjoy spectacular views Wildlife species include the an island where you will dine of Biscayne Bay, colorful Florida Panther, American amid tropical foliage. Evening orchids in the David A. Klein Crocodile, and West Indian cruises feature a dinner of Orchidarium, and the serene Manatee. If you enter through barbecued ribs and shrimp, gardens and the statues the Flamingo Main Entrance, with a variety revue and sing- that inhabit them. Located in make sure to stop and take along cruising back. There the southern side of Miami the 45-minute walk around may even be a sighting of in Coconut Grove, Vizcaya the Anhinga Trail, a partially macaws and rare birds from all welcomes visitors every day paved trail with a boardwalk over the world, alligator wres- except Tuesdays from 9:30 that stretches out over the tling, and Seminole Indians. am to 4:30 pm. water. Or, rent a bike and take The 550 passenger riverboat the 15 mile trail around Shark also includes a stop off at the Valley. These are both good Jungle Queen Indian Village, spots to see alligators in their a beautiful tropical island. natural habitat! Biography ENAR David L. DeMets, PhD is currently the Max Halperin Professor of Biostatistics and former Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin - Madison. He received his PhD 2015 in biostatistics in 1970 from the University of Minnesota. Following a postdoctoral appointment at the National Institutes of Health (1970- 72), he spent ten years (1972- Presidential Invited Speaker 1982) at the National Heart, Lung and Blood Institute at the National Institutes of Health where he was David L. DeMets, Ph.D. a member of and later became Max Halperin Professor of Biostatistics chief of the Biostatistics Branch. In 1982, he joined the University University of Wisconsin-Madison of Wisconsin and founded the Department of Biostatistics and Big Data, Big Opportunities, Big Challenges Medical Informatics which he chaired until 2009. Since the 1950’s, biostatisticians have been successfully He has co-authored four texts, engaged in biomedical research, from laboratory experi- Fundamentals of Clinical Trials, ments to observational studies to randomized clinical Data Monitoring in Clinical Trials: trials. We owe some of that success to the early pioneers, A Case Studies Approach and Data Monitoring Committees especially those biostatisticians who were present at the National Institutes in Clinical Trials: A Practical of Health (NIH). They created a culture of scientific collaboration, working on Perspective, and Statistical the methodology as needed to solve the biomedical research problems in Methods for Clinical Trials. design, conduct and analysis. Over the past 5 decades, we have experienced He has served on numerous NIH and industry-sponsored a tremendous increase in computational power, data storage capability and Data Safety and Monitoring multidimensionality of data, or “big data”. Some of this expansion has been Committees for clinical trials in driven by genomics. diverse disciplines. He served on the Board of Directors of the At present, we have the opportunity to contribute to the design and analysis American Statistical Association, of genomic data, data stored in the electronic health record and continued as well as having been President of the Society for Clinical Trials needs of clinical trials for greater efficiency. However, with these opportuni- and President of the Eastern ties, we have serious challenges starting with the fact that we need to develop North American Region (ENAR) new methodology to design and analyze the “big data” bases. The demand of the Biometric Society. In addition he was Elected Fellow for quantitative scientists exceeds the supply and there is no strategic national of the International Statistics plan to meet these demands. Institute in 1984, the American Statistical Association in 1986, the Federal funding for biomedical research has been flat and likely to remain Association for the Advancement so for several years, impacting both the ability to train additional quantitative of Science in 1998, the Society scientists and provide them with research funding for new methodologies. We for Clinical Trials in 2006 and the face new or more public scrutiny, demanding that our data and analysis be American Medical Informatics Association in 2008. In 2013, he shared earlier and earlier, even as the data are being gathered such as in clini- was elected as a member of the cal trials. Litigation is now part of our research environment. We will examine Institute of Medicine. His research some of these issues and speculate on ways forward. interests include the design, data monitoring and analysis of clinical trials, especially large Phase III randomized clinical trials. He is well known for his work on sequential statistical methods for monitoring interim data for early evidence of intervention benefit or possible harm.

18 ENAR 2015 | Spring Meeting | March 15–18 IMS Medallion Lecture

Tilmann Gneiting, Ph.D. Biography Heidelberg Institute for Theoretical Studies (HITS) Tilmann Gneiting is Group Karlsruhe Institute of Technology (KIT) Leader at Heidelberg Institute for Theoretical Studies (HITS) and Professor of Computational Uncertainty Quantification in Statistics at Karlsruhe Institute Complex Simulation Models of Technology (KIT) in Germany. In 1997, he obtained a PhD in Using Ensemble Copula Coupling Mathematics at Bayreuth University Critical decisions frequently rely on high-dimensional with Peter Huber as supervisor. output from complex computer simulation models that Subsequently, he held faculty show intricate cross-variable, spatial and/or temporal dependence struc- positions in the Department of Statistics at the University of tures, with weather and climate predictions being key examples. There is a Washington (1997-2009), where he strongly increasing recognition of the need for uncertainty quantification in remains affiliate faculty, and at the such settings, for which we propose and review a general multi stage proce- Institute for Applied Mathematics at dure called ensemble copula coupling (ECC), proceeding as follows. Heidelberg University (2009-2013). Tilmann’s research focuses on the 1. Generate a raw ensemble, consisting of multiple runs of the computer theory and practice of forecasting, model that differ in the inputs or model parameters in suitable ways. and spatial and spatio-temporal 2. Apply statistical postprocessing techniques, such as Bayesian model statistics, with applications to averaging or nonhomogeneous regression, to correct for systematic meteorological, hydrologic, and economic problems, among errors in the raw ensemble, to obtain calibrated and sharp predictive others. His work on probabilistic distributions for each univariate output variable individually. forecasting is supported by 3. Draw a sample from each postprocessed predictive distribution. an Advanced Grant from the European Research Council. 4. Rearrange the sampled values in the rank orderstructure of the raw Tilmann also serves as Editor for ensemble, to obtain the ECC postprocessed ensemble. Physical Science, Computing, Engineering, and the Environment The use of ensembles and statistical postprocessing have become rou- at the Annals of Applied Statistics tine in weather forecasting over the past decade. We show that seemingly (2011-2014). unrelated, recent advances can be interpreted, fused and consolidated within the framework of ECC, the common thread being the adoption of the empirical copula of the raw ensemble. In some settings, the adoption of the empirical copula of historical data offers an attractive alternative. In a case study, the ECC approach is applied to predictions of temperature, pressure, precipitation, and wind over Germany, based on the 50-member European Centre for Medium-Range Weather Forecasts (ECMWF) ensemble. This is joint work with Roman Schefzik and Thordis Thorarinsdottir.

Program 19 ENAR 2015

Short Courses

– Well-calibrated Bayesian clinical trial analy- SC1: ses; appropriate use of prior distributions Bayesian Clinical Trials – Drawing valid causal conclusions with FULL DAY | 8:00 am to 5:00 pm Bayesian analyses of observational clinical studies Tuttle (Terrace Level) – Bayesian meta-analysis for combining information David Draper University of California, Santa Cruz SC2: Overview Statistical Methods Experiments that would today be recognized as clinical trials have been performed at least for fMRI and EEG since the 1740s (with James Lind’s demonstra- Data Analysis tion that citrus fruits cure scurvy). From the late 19th century through the 1990s, sound infer- FULL DAY | 8:00 am to 5:00 pm ential design and analysis of clinical trials has Brickell (Terrace Level) largely been based on the frequentist probability paradigm, but there has been a recent recogni- Martin Lindquist tion that Bayesian methods can offer significant Johns Hopkins School of Public Health advantages in both design and analysis. Hernando Ombao The course University of California, Irvine – Optimal Bayesian design of clinical trials: sequential designs, adaptive designs; the Overview use of Bayesian decision theory for optimal This course will cover the state-of-the-art tech- design niques and statistical approaches for analyzing – Optimal Bayesian analysis of clinical trial fMRI and EEG data. Though there are many outcomes: what optimal analysis is, when it types of brain imaging modalities, these two can be achieved, and how to achieve it when are the most common. This course will be it’s possible scheduled for 4 hours and will be divided into 2 parts: the first devoted to analyzing fMRI data and the second to EEG data.

20 ENAR 2015 | Spring Meeting | March 15–18 The topics in the fMRI section include: methods of analysis. The workshop will focus on more (a) an overview of the acquisition and reconstruction advanced statistical topics such as studies involving of fMRI data more than one drug or schedule, patient heterogeneity, and bridging studies. Monitoring safety and efficacy (b) overview of the physiological basis of the fMRI simultaneously in dose expansion cohorts or as part of a signal Phase I/II trial will also be discussed as Phase I trials are (c) common experimental designs increasingly including aiming to further characterize the (d) pre-processing steps toxicity and efficacy profile. Illustrations on how to use model based designs, implement and carry out a model (e) methods for localizing areas activated by a task based Phase I trial in practice will be provided based on (f) connectivity analysis actual studies from oncology. Computational consider- (g) prediction and brain decoding. ations and available software will also be discussed. The topics for the EEG section are: The course (a) overview of the physiological basis of the – Overview of Phase I designs EEG signal – Basic theory of model based designs (b) common experimental designs – How good can a design be? Defining optimal (c) pre-processing steps including artifact rejection performance and filtering – Approaches to non-binary outcomes (d) spectral analysis – More complex problems: drug combinations, patient (e) coherence and connectivity analysis heterogeneity (f) statistical approaches to modeling variation across – Dose expansion cohorts trials and subjects – Phase I/II; estimating toxicity and efficacy (g) source localization. in the presence of bivariate endpoints – Statistical Theory (retrospective vs. prospective analysis, convergence, model robustness) SC3: – Protocol development, review of available software Design Considerations in Early Phase Clinical Trials: SC4: Phase I, Phase I/II Trials Personalized Medicine and FULL DAY | 8:00 am to 5:00 pm Dynamic Treatment Regimes Flagler (Terrace Level) HALF DAY | 8:00 am to 12:00 noon Monroe (Terrace Level) Ken Cheung Columbia University Marie Davidian Alexia Iasonos North Carolina State University Memorial Sloan Kettering Cancer Center Butch Tsiatis Overview North Carolina State University This course will cover design considerations specific to Phase I and Phase I/II clinical trials, dose finding studies Overview Personalized medicine is focused on making treat- in humans (not in healthy volunteers), in various disease ment decisions for an individual patient based on his/ settings. The topic is receiving increased attention in the her genetic/genomic, clinical, and other characteristics. statistical literature and as a result there exist several new Traditional approaches to this goal seek to develop new designs that can be made use of in any given situa- treatments that are tailored to specific subgroups of tion. The workshop will start with a review of the aims of patients with unique characteristics. An alternative objec- Phase I trials, Phase I trials with expansion cohorts, Ph I/ tive is to determine the best treatment for each patient, II trials and provide a link between the aims, designs, and not only those in a small subgroup, to the benefit of the entire patient population.

Program 21 This course will take this point of view and introduce basic concepts and methods for discovery of dynamic treatment regimes based on data. In the simplest case of a single treatment decision, a dynamic treatment regime is a rule that assigns treatment to patients based on their own characteristics, and the goal is to find the optimal regime, that leading to the greatest benefit if followed by all patients. In chronic diseases and disorders such as cancer, treatment decisions may be made at multiple time points. In this setting, a dynamic treatment regime is a set of sequential such decision rules corresponding to each decision point, and the optimal regime is the set of rules that would lead to greatest benefit if followed over the entire course of decision making by all patients. SC5: Data Science and High- Performance Statistical Computing HALF DAY | 1:00 pm to 5:00 pm Monroe (Terrace Level) Marc A. Suchard UCLA School of Public Health Martijn J. Schuemie Johnson & Johnson Overview Healthcare data are a prime research target for the Data Sciences because most databases are not only massive in size, but also very highly complex due to issues in sampling, the recording process, dependency through time and across individuals, and privacy in biomedicine. The size and complexity of these data present challenges to traditional statistical analysis that require novel method development and high-performance computing for scalability.

This course explores recent advances in large-scale statistical inference in healthcare as an example of Big Data in the Data Sciences. The course takes 4 hours and is divided into didactic lectures and hands-on, computing tutorials. Topics include massive observational healthcare databasing and wrangling, scaling inference tools that incorporate complex data structure, and high-performance imple- mentation using emerging computing technology. To this end, participants will use and develop open-source R packages, learn important design patterns for statistical computing, and discuss delegation of performance dependent hot-spots to C/C++ with multi-core and many-core parallelization (including on graphics processing units).

22 ENAR 2015 | Spring Meeting | March 15–18 ENAR 2015

Tutorials

Monday, March 16 predictive power and prediction intervals; T1: time-to-event endpoints, including stratified Group Sequential Designs populations and power for meta-analyses; binomial endpoints; superiority and non-inferi- Using the gsDesign R ority designs; information-based sample size Package and Web Interface re-estimation and conditional power designs 8:30 am – 10:15 am for sample size re-estimation; generation of publication-quality tables, figures and Flagler (Terrace Level) documents describing designs. Keaven Anderson Merck Research Laboratories T2: Graphics for Clinical Trials Description Group sequential design is the most widely- 10:30 am to 12:15 pm used and well-accepted form of adaptive Flagler (Terrace Level) design for confirmatory clinical trials. It controls Type I error for multiple analyses of a primary Frank E. Harrell Jr. endpoint during the course of a clinical trial Vanderbilt University School of Medicine and allows early, well-controlled evaluation of stopping for strong efficacy results or futility. Description This tutorial will review the basics of group This tutorial deals with some of the graphical sequential theory and demonstrate common displays that are useful for reporting clinical applications of the method. The R package trial results and for data monitoring commit- gsDesign and its graphical user interface will tee reports. Emphasis is placed on replacing be demonstrated to provide the user with an tables with graphics, new graphical displays easy-to-use, open source option for designing for adverse events, longitudinal data, subject group sequential clinical trials. The user should enrollment and exclusions, and reproducible leave the tutorial with an ability to propose reporting using R, LaTeX, and knitr. The philos- effective group sequential design solutions ophy of the approach is that tables should to confirmatory clinical trial design. Topics only support graphics, and they should be covered include: application of spending hyperlinked to graphics rather than appearing functions for selection of appropriate timing in the main report. Information that supports and levels of evidence for early stopping; graphics such as definitions and sample sizes confidence intervals; conditional power, are pop-ups in the pdf report. More details are available at biostat.mc.vanderbilt.edu/Greport.

Program 23 T4: A Tutorial for Multisequence Clinical Structural Brain MRI 3:45 pm – 5:30 pm Flagler (Terrace Level) Ciprian Crainiceanu, Ani Eloyan, Elizabeth Sweeney, and John Muschelli Johns Hopkins University Description High resolution structural magnetic resonance imaging (sMRI) is used extensively in clinical practice, as it provides detailed anatomical information of the living organism, is sensitive to many pathologies, and assists in the diagnosis of disease. Applications of sMRI cover essentially every part of the human body from toes to brain and a wide variety of diseases from stroke, cancer, and multiple sclerosis (MS), to internal bleeding and torn ligaments. Since the introduction of MRI in the 1980s, the noninvasive nature of the technique, the continuously improving resolution of images, and the wide availability of MRI scanners have made sMRI instantly recognizable T3: in the popular literature. Indeed, when one is asked to have an MRI in a clinical context it is almost certainly an Statistical Leadership in sMRI. These images are fundamentally different from Research and the Important functional MRI (fMRI) in size, complexity, measurement target, type of measurement, and intended use. While Role of Influence fMRI aims to study brain activity, sMRI reveals anatomical 1:45 pm – 3:30 pm information. This distinction is important as the scientific problems and statistical techniques for fMRI and sMRI Flagler (Terrace Level) analysis differ greatly, yet confusion between the two continues to exist in the statistical literature and among Bill Sollecito reviewers. Despite the enormous practical importance of University of North Carolina, Chapel Hill sMRI, few biostatisticians have made research contributions in this field. This may be due to the subtle aspects

Lisa LaVange of sMRI, the relatively flat learning curve, and the lack Food and Drug Administration of contact between biostatisticians and the scientists working in clinical neuroimaging. Our goal is reduce Description the price of entry, accelerate learning, and provide the This tutorial will first define leadership and its importance information required to progress from novice to initiated for statisticians; various leadership styles and skills will sMRI researcher. This tutorial will provide a gentle be introduced. The concept of emergent leadership will introduction to high resolution multisequence structural be illustrated using the research team environment as an MRI (sMRI) using several data sets. The tutorial will example of how statisticians can develop leadership skills. provide hands-on training in a variety of image process- The important role of influence as a leadership skill will be ing techniques including: data structure and visualization, given special emphasis as a way to develop leadership data storage and management, inhomogeneity correc- abilities and as a way to have a greater impact on the tion, spatial interpolation, skull stripping, spatial registra- teams and organizations in which statisticians work. tion, intensity normalization, lesion segmentation and mapping, and cross-sectional and longitudinal analysis of images. The tutorial will use R and several other free specialized brain imaging software.

24 ENAR 2015 | Spring Meeting | March 15–18 Tuesday, March 17 T6: T5: Graphical Approaches to Bayesian Computation using Multiple Test Problems PROC MCMC 3:45 pm – 5:30 pm 1:45 pm – 3:30 pm Jasmine (Terrace Level) Jasmine (Terrace Level) Dong Xi Fang Chen Novartis Pharmaceuticals SAS Institute Inc. Description Description Methods for addressing multiplicity are becoming The MCMC procedure is a general purpose Markov increasingly more important in clinical trials and other chain Monte Carlo simulation tool designed to fit a wide applications. In the recent past, several multiple test range of Bayesian models, including linear or nonlinear procedures have been developed that allow one to map models, multi-level hierarchical models, models with the relative importance of different study objectives nonstandard likelihood function or prior distributions, and as well as their relation onto an appropriately tailored missing data problems. This tutorial provides a quick and multiple test procedure, such as fixed-sequence, gentle introduction to PROC MCMC and demonstrates fallback, and gate keeping procedures. In this tutorial its use with a series of applications, such as Monte we focus on graphical approaches that can be applied Carlo simulation, various regression models, sensitivity to common multiple test problems, such as compar- analysis, random-effects models, and predictions. ing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, and Increasingly, Bayesian methods are being used by statis- combined non-inferiority and superiority testing. Using ticians in the pharmaceutical field to handle industry- graphical approaches, one can easily construct and specific problems. This tutorial will also present a number explore different test strategies and thus tailor the test of pharma-related data analysis examples and case procedure to the given study objectives. The resulting studies, including network meta-analysis, power prior, multiple test procedures are represented by directed, and missing data analysis. This tutorial is intended for weighted graphs, where each node corresponds to an statisticians who are interested in Bayesian computa- elementary hypothesis, together with a simple algorithm tion. Attendees should have a basic understanding of to generate such graphs while sequentially testing the Bayesian methods (the tutorial does not allocate time individual hypotheses. We also present several case covering basic concepts of Bayesian inference) and studies to illustrate how the approach can be used in experience using the SAS language. This tutorial is based clinical practice. In addition, we briefly consider power on SAS/STAT 13.2. and sample size calculation to optimize a multiple test procedure for given study objectives. The presented methods will be illustrated using the graphical user interface from the gMCP package in R, which is freely available on CRAN.

Program 25 ENAR 2015

Roundtables

Monday, March 16 | 12:15pm – 1:30pm Monroe (Terrace Level) R1: R2: Survival Strategies for New Trends and Junior Researchers: Innovations in Science and Can You Have It All? Practice of Clinical Trials Bhramar Mukherjee Olga Marchenko University of Michigan School of Public Health Quintiles Description Description As soon as you get a “real job” after complet- The intent of this roundtable discussion is to ing your doctoral or post-doctoral training, the highlight, share, and discuss the views on expectations and responsibilities from your some new trends and innovations in science employer increase dramatically. Unfortunately, and practice of clinical trials. Specific topics of this critical time window of establishing your- this discussion will include: self in the profession also coincides with the – Innovative designs (e.g., adaptive designs, phase when demands from your personal life biomarker-driven designs) escalate. I will share some useful strategies for where are we today? time management, carefully selecting research problems as a junior researcher, establishing – Statistical and PK/PD applications on smart independence from your advisor, prioritizing in phones to collect data (e.g., patient diary), terms of teaching, research, collaboration and to adjust doses (e.g., a dose for diabetes professional service opportunities and ultimately patients), to analyze data (e.g., simple sum- for trying to strike a work-life balance. maries and graphics) just an idea or the reality? It is a complex multi-dimensional optimization – Statistical and operational simulations problem with non-linear constraints, and while why do we need them? there is no uniform and obvious solution that – Predictive analytics to improve operational works for everybody, we can take advantage of support should we statisticians step up? shared experiences and existing resources to maximize our chance of success, in both personal and professional terms. This discussion will be relevant for senior graduate students, post-doctoral researchers, junior researchers in both industry and academia who are planning to enter/have recently entered the work force.

26 ENAR 2015 | Spring Meeting | March 15–18 R3: R5: The Role of Statisticians at Survival Skills for Biostatisticians the FDA in Academic Medical Centers Dionne L. Price Mithat Gönen Food and Drug Administration Memorial Sloan-Kettering Cancer Center Description Description The Food and Drug Administration (FDA) is composed of Biostatisticians in academic medical centers face dif- seven centers which collectively employ over 250 stat- ferent challenges than their counterparts in universities isticians. Statisticians at the FDA are an integral part of and academia. This will be an informal discussion of multidisciplinary teams dedicated to assuring the safety these challenges. Possible topics to be covered include and efficacy of human and veterinary drugs, biologi- the double-edged nature of collaborative work, manag- cal products, medical devices, our nation’s food supply, ing the collaborations to sustain funding, find intellectual cosmetics, and products that emit radiation. Statisticians fulfillment and stimulation for one’s own methodological Monday, March 16 | 12:15pm – 1:30pm analyze and evaluate data, provide leadership, promote work, avoiding being overwhelmed and demotivated by innovation in study designs and statistical techniques, the amount and nature of collaborations, gaining accep- Monroe (Terrace Level) and conduct methodological research aimed at address- tance as an intellectual contributor (as opposed to being ing the many complex issues that arise in a regulatory a p-value generator) from one’s collaborators and striking environment. FDA statisticians utilize their statistical train- work-life balance. ing and knowledge to directly impact the public health. Roundtable participants will learn the role of statisticians at the FDA and potential paths to successful careers with R6: the Agency. Working as a Statistician at the Center for Devices at the FDA R4: Telba Irony Applying Bayesian Evidence Food and Drug Administration Synthesis in Comparative Description Effectiveness Research In this round table, I will discuss the life of statistician at the Center for Devices and Radiological Health, highlight- David Ohlssen ing the fact that the statistician is a problem solver, who Novartis Pharmaceuticals must be interested in science and teaching, and could Description aspire to leadership positions. Motivated by the use of evidence based medicine to evaluate health technology, there has been an enormous R7: increase in the use of quantitative techniques that allow data to be combined from a variety of sources. In a drug Writing Collaborative Grant development setting, there have been a number of recent Applications: Tips and Strategies key works: The recommendations on the use and application of network meta-analysis were recently presented Brisa Sánchez by the ISPOR task force; From a regulatory perspective, University of Michigan School of Public Health the work of the Canadian Agency (Indirect Evidence: Indirect Treatment Comparisons in Meta-Analysis) and Description the UK NICE Evidence synthesis series have recently One of the key aspects of a biostatistics career in aca- been published; Further, the FDA also started a number demia undoubtedly includes participation in collabora- of recent projects on comparative effectiveness research tive research and writing grant proposals to support that as part of a plan to enhance regulatory science. By draw- research. In this round table we will discuss the range ing on examples from a drug development setting, this of contributions statisticians make to the grant writing roundtable aims to discuss these recent advances. process, share tips and strategies to make the process more efficient, and discuss how participation in collaborative grant proposals can enhance the biostatistician’s methodological research.

Program 27 R8: R9: Interplay Between Adaptive Publishing Without Perishing: Design Features and Complex Strategies for Success in Study Subjectives, Case Studies Publishing in and Tools (Bio)statistical Journals Yevgen Tymofyeyev Marie Davidian Janssen Research & Development North Carolina State University Description Description The current state of available commercial implementa- Contributing to the advance of our discipline through tions of adaptive designs software covers substantial publication of articles in peer-reviewed journals is a fun- practical needs. On the other hand, there are also prac- damental expectation for both junior and not-so junior tical situations where a need exists for custom-made biostatistical researchers alike. Success in publishing programming to satisfy requirements and special fea- one’s work ensures that it will be widely disseminated tures of a particular study or program. Such cases are to researchers and practitioners who stand to benefit. hard to envision up-front in order to warrant a commer- In addition, funding agencies and academic institutions cial off-the-shelf tool. An example could be a study with place considerable importance on a successful record of multiple doses of the active drug, multiple comparators publication. Accordingly, understanding the peer review and several primary endpoints, where the corresponding and editorial processes of top journals and mastering multiple tests can be organized into some logical struc- the art of writing an effective journal article are keys to ture resolved by the application of a gatekeeping- type success in publishing. How does one determine the best procedure, to address the multiple testing problem. This outlet for one’s work? What are the essential elements roundtable is intended to share experiences of interesting of a successful journal article? How does one maximize case studies addressing not only statistical design and the chance of acceptance? What strategies can ensure simulation components, but also logistical implementa- that a published paper is read and cited? How does tion issues and interactions with regulatory agencies. one make optimal use of limited space and additional supplementary material in conveying the message? What are the roles of the editor, associate editor, and referees? What considerations do editors use when evaluating a paper? This roundtable will provide a forum for candid discussion of these and other questions.

28 ENAR 2015 | Spring Meeting | March 15–18 ENAR 2015

Program Summary

SATURDAY, MARCH 14

9:00 am – 9:00 pm WORKSHOP FOR JUNIOR RESEARCHERS Hibiscus B (Terrace Level)

3:30 pm – 5:30 pm CONFERENCE REGISTRATION Lower Promenade (Terrace Level)

SUNDAY, MARCH 15

7:30 am – 6:30 pm CONFERENCE REGISTRATION Lower Promenade (Terrace Level)

8:00 am – 12:00 pm SHORT COURSES

SC4: Personalized Medicine and Dynamic Monroe (Terrace Level) Treatment Regimes

8:00 am – 5:00 pm SHORT COURSES

SC1: Bayesian Clinical Trials Tuttle (Terrace Level)

SC2: Statistical Methods for fMRI and EEG Data Analysis Brickell (Terrace Level)

SC3: Design Considerations in Early Phase Clinical Flagler (Terrace Level) Trials: Phase I, Phase I/II Trials

12:30 am – 5:30 pm DIVERSITY WORKSHOP Orchid CD (Terrace Level)

Program 29 1:00 pm – 5:00 pm SHORT COURSES

SC5: Data Science and High-Performance Monroe (Terrace Level) Statistical Computing

3:00 pm – 6:00 pm EXHIBITS OPEN Lower Promenade (Terrace Level)

4:30 pm – 7:00 pm ENAR EXECUTIVE COMMITTEE MEETING Orchid A (Terrace Level) (by Invitation Only)

4:00 pm – 6:30 pm PLACEMENT SERVICE Hibiscus A (Terrace Level)

7:30 pm – 8:00 pm NEW MEMBER RECEPTION Riverfront Ballroom (Terrace Level)

8:00 pm – 11:00 pm SOCIAL MIXER AND POSTER SESSION Riverfront Ballroom (2nd Floor)

1. Posters: Latent Variable and Mixture Models

2. Posters: Imaging Methods and Applications

3. Posters: Clinical Trials, Adaptive Designs and Applications

4. Posters: Survival Analysis

5. Posters: Causal Inference

6. Posters: Statistical Genetics, GWAS, and ‘omics Data

7. Posters: Methodology and Applications in Epidemiology, Environment, and Ecology

8. Posters: Variable Selection and Methods for High Dimensional Data

9. Posters: Bayesian Methods and Computational Algorithms

30 ENAR 2015 | Spring Meeting | March 15–18 MONDAY, MARCH 16

7:30 a.m – 5:00 pm CONFERENCE REGISTRATION Lower Level Promenade (Terrace Level)

7:30 am – 5:00 pm SPEAKER READY ROOM Azalea B (Terrace Level)

9:00 am – 5:00 pm PLACEMENT SERVICE Hibiscus A (Terrace Level)

8:30 am – 5:30 pm EXHIBITS OPEN Lower Promenade (Terrace Level)

8:30 am – 10:15 am TUTORIAL

T1: Group Sequential Designs Using the gsDesign R Flagler (Terrace Level) Package and Web Interface

SCIENTIFIC PROGRAM

10. Advances in Patient-Centered Outcomes (PCOR) Ashe Auditorium Methodology (3rd Floor)

11. Looking Under the Hood: Assumptions, Methods Brickell (Terrace Level) and Applications of Microsimulation Models to Inform Health Policy

12. Optimal Inference for High Dimensional Problems Miami Lecture Hall (3rd Floor)

13. Lifetime Data Analysis Highlights Johnson (3rd Floor)

14. Recent Advances and Challenges in the Design Foster (3rd Floor) of Early Stage Cancer Trials

15. Large Scale Data Science for Observational Tuttle (Terrace Level) Healthcare Studies

16. Contributed Papers: Competing Risks Ibis (3rd floor)

Program 31 17. Contributed Papers: Applications and Methods Pearson I (3rd Floor) in Environmental Health

18. Contributed Papers: Statistical Methods Orchid C (Terrace Level) for Genomics

19. Contributed Papers: Spatial and Spatio-Temporal Merrick II (3rd Floor) Methods and Applications

20. Contributed Papers: Case Studies in Longitudinal Pearson II (3rd Floor) Data Analysis

21. Contributed Papers: Meta Analysis Gautier (3rd Floor)

22. Contributed Papers: Semi-Parametric Methods Stanford (3rd Floor)

9:30 am – 4:30 pm PLACEMENT SERVICE Hibiscus A (Terrace Level)

10:15 am – 10:30 am REFRESHMENT BREAK WITH OUR EXHIBITORS Lower Promenade (Terrace Level)

10:30 am – 12:15 pm TUTORIAL

T2: Graphics for Clinical Trials Flagler (Terrace Level)

SCIENTIFIC PROGRAM

23. Trends and Innovations in Clinical Trial Statistics: Tuttle (Terrace Level) “The Future ain’t What it Used to be”

24. Causal Inference in HIV/AIDS Research Foster (3rd Floor)

25. Open Problems and New Directions in Merrick II (3rd Floor) Neuroimaging Research

26. Statistical Methods for Understanding Whole Johnson (3rd Floor) Genome Sequencing

27. Doing Data Science: Straight Talk from the Frontline Brickell (Terrace Level)

32 ENAR 2015 | Spring Meeting | March 15–18 28. IMS Medallion Lecture Ashe Auditorium (3rd Floor)

29. In Memory of Marvin Zelen: Past, Present and Miami Lecture Hall Future of Clinical Trials and Cancer Research (3rd Floor)

30. Contributed Papers: Methods for Clustered Data Pearson I (3rd Floor) and Applications

31. Contributed Papers: GWAS Ibis (3rd Floor)

32. Contributed Papers: Applications, Simulations and Pearson II (3rd Floor) Methods in Causal Inference

33. Contributed Papers: Adaptive Designs and Dynamic Gautier (3rd Floor) Treatment Regimes

34. Contributed Papers: Survival Analysis and Cancer Stanford (3rd Floor) Applications

INVITED AND CONTRIBUTED ORAL POSTERS

35. Oral Posters: Methods and Applications in Jasmine (Terrace Level) High Dimensional Data and Machine Learning

12:15 pm – 1:30 pm ROUNDTABLE LUNCHEONS Monroe (Terrace Level)

12:30 pm – 4:30 pm REGIONAL ADVISORY BOARD (RAB) Hibiscus B (Terrace Level) LUNCHEON MEETING (by Invitation Only)

Program 33 1:45 pm – 3:30 pm TUTORIAL

T3: Statistical Leadership in Research and the Flagler (Terrace Level) Important Role of Influence

SCIENTIFIC PROGRAM

36. Recent Research in Adaptive Randomized Trials with Ashe Auditorium the Goal of Addressing Challenges in Regulatory (3rd Floor) Science

37. Statistical Innovations in Functional Genomics Johnson (3rd Floor) and Population Health

38. Big Data: Issues in Biosciences Miami Lecture Hall (3rd Floor)

39. Recent Advances in Statistical Ecology Foster (3rd Floor)

40. New Analytical Issues in Current Brickell (Terrace Level) Epidemiology Studies of HIV and Other Sexually Transmitted Infections

41. Statistical Advances and Challenges in Mobile Health Tuttle (Terrace Level)

42. Contributed Papers: Survey Research Pearson I (3rd Floor)

43. Contributed Papers: Graphical Models Pearson II (3rd Floor)

44. Contributed Papers: Joint Models for Longitudinal Merrick II (3rd Floor) and Survival Data

45. Contributed Papers: Functional Data Analysis Gautier (3rd Floor)

46. Contributed Papers: Methods in Causal Inference: Ibis (3rd Floor) Instrumental Variable, Propensity Scores and Matching

47. Contributed Papers: Covariates Measured with Error Stanford (3rd Floor)

34 ENAR 2015 | Spring Meeting | March 15–18 INVITED AND CONTRIBUTED ORAL POSTERS

48. Oral Posters: Clinical Trials Jasmine (Terrace Level)

3:30 pm – 3:45 pm REFRESHMENT BREAK WITH OUR EXHIBITORS Lower Promenade (Terrace Level)

3:45 pm – 5:30 pm TUTORIAL

T4: A Tutorial for Multisequence Clinical Structural Flagler (Terrace Level) Brain MRI

SCIENTIFIC PROGRAM

49. CENS Invited Session — Careers in Statistics: Ashe Auditorium Skills for Success

50. Analysis Methods for Data Obtained from Tuttle (Terrace Level) Electronic Health Records

51. Statistical Challenges of Survey and Surveillance Foster (3rd Floor) Data in US Government

52. Reconstructing the Genomic Landscape from Johnson (3rd Floor) High-Throughput Data

53. Statistical Methods for Single Miami Lecture Hall Molecule Experiments (3rd Floor)

54. Subgroup Analysis and Adaptive Trials Brickell (Terrace Level)

Program 35 55. Contributed Papers: Methods to Assess Agreement Pearson I (3rd Floor)

56. Contributed Papers: Methylation and RNA Stanford (3rd Floor) Data Analysis

57. Contributed Papers: New Developments in Imaging Ibis (3rd Floor)

58. Contributed Papers: Latent Variable and Principal Pearson II (3rd Floor) Component Models

59. Contributed Papers: Developments and Gautier (3rd Floor) Applications of Clustering, Classification, and Dimension Reduction Methods

60. Contributed Papers: Survival Analysis: Merrick II (3rd Floor) Methods Development and Applications

INVITED AND CONTRIBUTED ORAL POSTERS

61. Oral Posters: GWAS and Meta Analysis Jasmine (Terrace Level) of Genetic Studies

5:30 pm – 6:30 pm CENS STUDENT MIXER Monroe (Terrace Level)

6:30 pm – 7:30 pm PRESIDENT’S RECEPTION (by Invitation Only) Riverwalk Outdoor Terrace

36 ENAR 2015 | Spring Meeting | March 15–18 TUESDAY, MARCH 17

7:30 am – 5:00 pm CONFERENCE REGISTRATION Lower Promenade (Terrace Level)

7:30 am – 5:00 pm SPEAKER READY ROOM Azalea B (Terrace Level)

8:30 am – 5:30 pm EXHIBITS OPEN Lower Promenade (Terrace Level)

9:30 am – 3:30 pm PLACEMENT SERVICE Hibiscus A (Terrace Level)

8:30 am – 10:15 am SCIENTIFIC PROGRAM

62. Statistical Inference with Random Hibiscus B (Terrace Level) Forests and Related Ensemble Methods

63. Mediation and Interaction: Theory, Pratice and Ashe Auditorium Future Directions (3rd Floor)

64. Motivation and Analysis Strategies for Joint Orchid C (Terrace Level) Modeling of High Dimensional Data in Genetic Association Studies

65. Recent Developments on Inference for Possibly Johnson (3rd Floor) Time-Dependent Treatment Effects with Survival Data

66. Journal of Agricultural, Biological and Foster (3rd Floor) Environmental Statistics (JABES) Highlights

67. Estimation and Inference for High Dimensional Miami Lecture Hall and Data Adaptive Problems (3rd Floor)

68. Contributed Papers: Novel Methods Merrick I (3rd Floor) for Bioassay Data

Program 37 69. Contributed Papers: Infectious Disease Pearson I (3rd Floor)

70. Contributed Papers: Variable Selection Pearson II (3rd Floor)

71. Contributed Papers: Modeling Health Data Gautier (3rd Floor) with Spatial or Temporal Features

72. Contributed Papers: Advances in Merrick II (3rd Floor) Longitudinal Modeling

73. Contributed Papers: Causal Inference: Ibis (3rd Floor) Average and Mediated Effects

74. Contributed Papers: Variable Selection Stanford (3rd Floor) with High Dimensional Data

10:15 am – 10:30 am REFRESHMENT BREAK WITH OUR EXHIBITORS Lower Promenade (Terrace Level)

10:30 am – 12:15 pm 75. PRESIDENTIAL INVITED ADDRESS Regency Ballroom (Terrace Level)

12:30 pm – 4:30 pm REGIONAL COMMITTEE LUNCHEON MEETING Hibiscus B (Terrace Level) (by Invitation Only)

38 ENAR 2015 | Spring Meeting | March 15–18 1:45 pm – 3:30 pm TUTORIAL

T5: Bayesian Computation Using Proc MCMC Jasmine (Terrace Level)

SCIENTIFIC PROGRAM

76. Recent Advances in Dynamic Treatment Regimes Ashe Auditorium (3rd Floor)

77. Predictive Models for Precision Medicine Miami Lecture Hall (3rd Floor)

78. Electronic Health Records: Challenges Orchid C (Terrace Level) and Opportunities

79. Cost-Effective Study Designs for Observational Data Tuttle (Terrace Level)

80. Advanced Machine Learning Methods Johnson (3rd Floor)

81. Statistical Analysis for Deep Sequencing Data Foster (3rd Floor) in Cancer Research: Methods and Applications

82. Spatial and Spatio-Temporal Modeling Merrick II (3rd Floor)

83. Contributed Papers: Study Design and Power Stanford (3rd Floor)

84. Contributed Papers: Missing Data Gautier (3rd Floor)

85. Contributed Papers: Innovative Methods Ibis (3rd Floor) for Clustered Data

86. Contributed Papers: Biopharmaceutical Pearson II (3rd Floor) Applications and Survival Analysis

87. Contributed Papers: Computational Methods Pearson I (3rd Floor)

3:30 pm – 3:45 pm REFRESHMENT BREAK WITH OUR EXHIBITORS Lower Promenade (Terrace Level)

Program 39 3:45 pm – 5:30 pm TUTORIAL

T6: Graphical Approaches to Multiple Test Problems Jasmine (Terrace Level)

SCIENTIFIC PROGRAM

88. Biostatistical Methods for Heterogeneous Tuttle (Terrace Level) Genomic Data

89. Innovative Approaches in Competing Risk Analysis Orchid C (Terrace Level)

90. Biomarker Evaluation in Diagnostics Studies Johnson (3rd Floor) with Longitudinal Data

91. Solving Clinical Trial Problems by Using Foster (3rd Floor) Novel Designs

92. Ensuring Biostatistical Competence Using Miami Lecture Hall Novel Methods (3rd Floor)

93. Methodological Frontiers in the Analysis of Panel Ashe Auditorium (3rd Observed Data Floor)

94. Contributed Papers: Ordinal and Categorical Data Stanford (3rd Floor)

95. Contributed Papers: Statistical Genetics Merrick II (3rd Floor)

96. Contributed Papers: Ecology and Pearson I (3rd Floor) Forestry Applications

97. Contributed Papers: Pooled Biospecimens Pearson II (3rd Floor) and Diagnostic Biomarkers

98. Contributed Papers: Multiple Testing Ibis (3rd Floor) and Variable Selection

99. Contributed Papers: Parameter Estimation Gautier (3rd Floor) in Hierarchical and Non Linear Models

5:30 pm – 6:30 pm ENAR BUSINESS MEETING Orchid C (Terrace Level) (Open to all ENAR Members)

6:30 pm – 9:30 pm TUESDAY NIGHT EVENT Dinner Cruise on the Biscayne Lady

40 ENAR 2015 | Spring Meeting | March 15–18 WEDNESDAY, MARCH 18

7:30 am – 12:00 noon SPEAKER READY ROOM Azalea B (Terrace Level)

7:30 am – 9:00 am PLANNING COMMITTEE BREAKFAST MEETING Orchid A (Terrace Level) (by Invitation Only)

8:00 am – 12:30 pm CONFERENCE REGISTRATION Lower Promenade (Terrace Level)

8:00 am – 12:00 pm EXHIBITS OPEN Lower Promenade (Terrace Level)

8:30 am – 10:15 am SCIENTIFIC PROGRAM

100. New Statistical Methods in the Environmental Miami Lecture Hall Health Sciences (3rd Floor)

101. Novel Phase II and III Clinical Trial Designs for Pearson (3rd Floor) Cancer Research that Incorporate Biomarkers and Nonstandard Endpoints

102. Novel Statistical Methods to Decipher Gene Jasmine (Terrace Level) Regulation Using Sequence Data

103. Flow Cytometry: Data Collection and Foster (3rd Floor) Statistical Analysis

104. Statistical Methods in Chronic Kidney Disease Johnson (3rd Floor)

105. Challenging Statistical Issues in Imaging Merrick I (3rd Floor)

106. Statistical Methods for Predicting Subgroup Level Ashe Auditorium Treatment Response (3rd Floor)

107. Contributed Papers: ROC Curves Ibis (3rd Floor)

108. Contributed Papers: Personalized Medicine Merrick II (3rd Floor) and Biomarkers

109. Contributed Papers: Time Series Analysis Stanford (3rd Floor) and Methods

Program 41 10:15 am – 10:30 am REFRESHMENT BREAK WITH OUR EXHIBITORS Lower Promenade (Terrace Level)

10:30 am – 12:15 pm SCIENTIFIC PROGRAM

110. Incorporating Biological Information in Statistical Jasmine (3rd Floor) Modeling of Genome-Scale Data with Complex Structures

111. Emerging Issues in Clinical Trials and High Ashe Auditorium Dimensional Data (3rd Floor)

112. Advances in Repeated Measures and Longitudinal Pearson (3rd Floor) Data Analysis

113. Advances in Modeling Zero-Inflated Data Johnson (3rd Floor)

114. New Developments in Missing Data Analysis: Merrick II (3rd Floor) from Theory to Practice

115. Environmental Methods with Deterministic and Foster (3rd Floor) Stochastic Components

116. Bayesian and non-parametric Bayesian Miami Lecture Hall Approaches to Causal Inference (3rd Floor)

117. Design of Multiregional Clinical Trials: Merrick I (3rd Floor) Theory and Practice

118. Contributed Papers: Multivariate Survival Analysis Ibis (3rd Floor)

119. Contributed Papers: Constrained Inference Stanford (3rd Floor)

120. Contributed Papers: Nonparametric Methods Gautier (3rd Floor)

42 ENAR 2015 | Spring Meeting | March 15–18 Program 43 ENAR 2015

Scientific Program

SUNDAY, MARCH 15

8:00 am – 11:00 pm POSTER PRESENTATIONS Riverfront Ballroom (2nd Floor)

1. POSTERS: Latent Variable and Mixture Models Sponsor: ENAR 1a. INVITED POSTER: Assessment of Dimensionality Can Be Distorted by Too Many Zeroes: An Example from Psychiatry and a Solution Using Mixture Models Melanie M. Wall*, Columbia University Irini Moustaki, London School of Economics 1b. Local Influence Diagnostics for Hierarchical Count Data Models with Overdispersion and Excess Zeros Trias Wahyuni Rakhmawati*, Universiteit Hasselt Geert Molenberghs, Universiteit Hasselt and Katholieke Universiteit Leuven Geert Verbeke, Katholieke Universiteit Leuven and Universiteit Hasselt Christel Faes, Universiteit Hasselt and Katholieke Universiteit Leuven 1c. Finite Multivariate Mixtures of Skew-t Distributions with Collapse Clusters with Application in Forestry Josef Hoefler* and Donna Pauler Ankerst, Technical University Munich 1d. Weibull Mixture Regression for Zero-Heavy Continuous Substance Use Outcomes Mulugeta Gebregziabher, Delia Voronca* and Abeba Teklehaimanot, Medical University of South Carolina Elizabeth J. Santa Ana, Ralph H. Johnson Department of Veterans Affairs Medical Center 1e. Model-Free Estimation of Time-Varying Correlation Coefficients and their Confidence Intervals with an Application to fMRI Data Maria A. Kudela* and Jaroslaw Harezlak, Indiana University Richard M. Fairbanks School of Public Health, Indianapolis Martin Lindquist, Johns Hopkins Bloomberg School of Public Health

44 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 1f. Zero-and-One Inflated Beta Regression with Mixed Effects for Modeling Relative Frequency of Condom Use in Men Who Have Sex with Men (MSM) in Ghana Nanhua Zhang*, Cincinnati Children’s Hospital Medical Center Yue Zhang, University of Cincinnati LaRon E. Nelson, University of Rochester 1g. Inference for the Number of Topics in the Latent Dirichlet Allocation Model via a Pseudo-Marginal Metropolis-Hastings Algorithm Zhe Chen* and Hani Doss, University of Florida 1h. Applying a Stochastic Volatility Model to US Stock Markets with a UMM Undergraduate Student Jong-Min Kim* and Li Qin, University of Minnesota, Morris 1i. A Mixture Model of Heterogeneity in Treatment Response Hongbo Lin* and Changyu Shen, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis 1j. Bayesian Random Graph Mixture Model for Community Detection in Weighted Networks Christopher Bryant*, Mihye Ahn, Hongtu Zhu and Joseph Ibrahim, University of North Carolina, Chapel Hill 1k. Time Series Forecasting Using Model-Based Clustering and Model Averaging Fan Tang* and Joseph Cavanaugh, University of Iowa 1l. Multilevel Functional Principal Components Analysis of Surfaces with Application to CT Image Data of Pediatric Thoracic Shape Lucy F. Robinson*, Jonathan Harris and Sriram Balasubramanian, Drexel University 1m. A New Approach for Treatment Noncompliance with Structural Zero Data Pan Wu*, Christiana Care Health System

* = Presenter n = Student Award Winner Program 45 2. POSTERS: Imaging Methods and Applications Sponsor: ENAR 2a. INVITED POSTER: Determining Multimodal Neuroimaging Markers of Parkinson’s Disease DuBois Bowman*, Columbia University Weingiong Xue, Boehringer Ingelheim Daniel Drake, Columbia University 2b. Segmentation of Intracerebral Hemorrhage in CT Scans Using Logistic Regression John Muschelli*, Johns Hopkins Bloomberg School of Public Health Natalie Ullman and Daniel Hanley, Johns Hopkins School of Medicine Ciprian M. Crainiceanu, Johns Hopkins Bloomberg School of Public Health 2c. Relating Multi-Sequence Longitudinal Data from MS Lesions on Structural MRI to Clinical Covariates and Outcomes Elizabeth Sweeney*, Johns Hopkins Bloomberg School of Public Health Blake Dewey and Daniel Reich, National Institute of Neurological Disease and Stroke, National Institutes of Health Ciprian M. Crainiceanu, Johns Hopkins Bloomberg School of Public Health Russell Shinohara, University of Pennsylvania Ani Eloyan, Johns Hopkins Bloomberg School of Public Health 2d. Using Multiple Imputation to Efficiently Correct Magnetic Resonance Imaging Data in Multiple Sclerosis Alicia S. Chua*, Svetlana Egorova, Mark C. Anderson, Mariann Polgar-Turcsanyi, Tanuja Chitnis, Howard L. Weiner, Charles R. Guttmann, Rohit Bakshi and Brian C. Healy, Brigham and Women’s Hospital, Boston 2e. Background Adjustment and Voxelwise Inference for Template-Based Gaussian Mixture Models Meng Li* and Armin Schwartzman, North Carolina State University 2f. Fast, Fully Bayesian Spatiotemporal Inference for fMRI Donald R. Musgrove*, John Hughes and Lynn E. Eberly, University of Minnesota 2g. Bayesian Spatial Variable Selection for Ultra-High Dimensional Neuroimaging Data: A Multiresolution Approach Yize Zhao*, Statistical and Applied Mathematical Sciences Institute Jian Kang and Qi Long, Emory University 2h. Analysis of High Dimensional Brain Signals in Designed Experiments Using Penalized Threshold Vector Autoregression Lechuan Hu* and Hernando Ombao, University of California, Irvine

46 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 2i. Spatially Weighted Reduced-Rank Framework for Neuroimaging Data with Application to Alzheimer’s Disease Mihye Ahn*, University of Nevada, Reno Haipeng Shen and Chao Huang, University of North Carolina, Chapel Hill Yong Fan, University of Pennsylvania Hongtu Zhu, University of North Carolina, Chapel Hill 2j. Highly Adaptive Test for Group Differences in Brain Functional Connectivity Junghi Kim* and Wei Pan, University of Minnesota 2k. Pre-Surgical fMRI Data Analysis Using a Spatially Adaptive Conditionally Autoregressive Model Zhuqing Liu* and Veronica J. Berrocal, University of Michigan Andreas J. Bartsch, University of Heidelberg Timothy D. Johnson, University of Michigan 2l. Semiparametric Bayesian Models for Longitudinal MR Imaging Data with Multiple Continuous Outcomes Xiao Wu*, University of Florida Michael J. Daniels, University of Texas, Austin 2m. Improving Reliability of Subject-Level Resting-State Brain Parcellation with Empirical Bayes Shrinkage Amanda F. Mejia*, Mary Beth Nebel and Haochang Shou, Johns Hopkins University Ciprian M. Crainiceanu, Johns Hopkins Bloomberg School of Public Health James J. Pekar, Johns Hopkins University School of Medicine Stewart Mostofsky, Brian Caffo and Martin Lindquist, Johns Hopkins University

3. POSTERS: Clinical Trials, Adaptive Designs and Applications Sponsor: ENAR 3a. INVITED POSTER: The Role of Statisticians in Regulatory Drug Safety Evaluation Clara Kim* and Mark Levenson, U.S. Food and Drug Administration 3b. Analyzing Multiple Endpoints in a Confirmatory Randomized Clinical Trial: An Approach that Addresses Stratification, Missing Values, Baseline Imbalance and Multiplicity for Strictly Ordinal Outcomes Hengrui Sun*, University of North Carolina, Chapel Hill Atsushi Kawaguchi, Kyoto University, Japan Gary Koch, University of North Carolina, Chapel Hill 3c. Comparing the Statistical Power of Analysis of Covariance after Multiple Imputation and the Mixed Model in Testing the Treatment Effect for Pre-Post Studies with Loss to Follow-Up Wenna Xi*, Michael L. Pennell, Rebecca R. Andridge and Electra D. Paskett, The Ohio State University

* = Presenter n = Student Award Winner Program 47 3d. Extending Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Vaccine-Vaccine Interactions in Vaccine Safety Surveillance Kijoeng Nam*, U.S. Food and Drug Administration Nicholas C. Henderson, University of Wisconsin, Madison Patricia Rohan, Emily Jane Woo and Estelle Russek-Cohen, U.S. Food and Drug Administration 3e. Dose-Finding Approach Based on Efficacy and Toxicity Outcomes in Phase I Oncology Trials for Molecularly Targeted Agents Hiroyuki Sato*, Pharmaceuticals and Medical Devices Agency Akihiro Hirakawa, Nagoya University Graduate School of Medicine Chikuma Hamada, Tokyo University of Science 3f. Effect Size Measures and Meta-Analysis for Alternating Treatment Single Case Design Data D Leann Long*, Mathew Bruckner, Regina A. Carroll and George A. Kelley, West Virginia University 3g. Clinical Trials with Exclusions Based on Race, Ethnicity, and English Fluency Brian L. Egleston*, Omar Pedraza, Yu-Ning Wong, Roland L. Dunbrack Jr., Eric A. Ross and J. Robert Beck, Fox Chase Cancer Center, Temple University 3h. Comparing Four Methods for Estimating Optimal Tree-Based Treatment Regimes Aniek Sies* and Iven Van Mechelen, Katholieke Universiteit Leuven 3i. Comparing Methods of Adjusting for Center Effects Using Pediatric ICU Glycemic Control Data Samantha Shepler*, Scott Gillespie and Traci Leong, Emory University 3j. Bayesian Dose Finding Procedure Based on Information Criterion Lei Gao*, Sanofi William F. Rosenberger, George Mason University Zorayr Manukyan, Pfizer Inc. 3k. The Relationship among Toxicity, Response, and Survival Profiles Ultimately Influence Calling a Beneficial Experimental Drug Favorable Under Standard Phase I, II, and III Clinical Trial Designs Amy S. Ruppert* and Abigail B. Shoben, The Ohio State University 3l. Dose-Finding Using Hierarchical Modeling for Multiple Subgroups Kristen May Cunanan* and Joseph S. Koopmeiners, University of Minnesota 3m. Detecting Outlying Trials in Network Meta-Analysis Jing Zhang*, University of Maryland Haoda Fu, Eli Lilly and Company Bradley P. Carlin, University of Minnesota 3n. INVITED POSTER: Subgroup Analysis in Confirmatory Clinical Trials Brian Millen*, Eli Lilly and Company

48 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 4. POSTERS: Survival Analyses Sponsor: ENAR 4a. INVITED POSTER: Time Dependent Covariates in the Presence of Left Truncation Rebecca A. Betensky*, Harvard School of Public Health 4b. On the Estimators and Tests for the Semiparametric Hazards Regression Model Seung-Hwan Lee*, Illinois Wesleyan University 4c. A Martingale Approach to Estimating Confidence Band with Censored Data Eun-Joo Lee*, Millikin University 4d. Novel Image Markers for Non-Small Cell Lung Cancer Classification and Survival Prediction Hongyuan Wang*, University of Kentucky Fuyong Xing and Hai Su, University of Florida Arnold Stromberg, University of Kentucky Lin Yang, University of Florida 4e. Generalized Estimating Equations for Modeling Restricted Mean Survival Time Under General Censoring Mechanisms Xin Wang* and Douglas E. Schaubel, University of Michigan 4f. Generalized Accelerated Failure Time Spatial Frailty Model Haiming Zhou*, Timothy Hanson and Jiajia Zhang, University of South Carolina 4g. Penalized Variable Selection in Competing Risks Regression Zhixuan Fu*, Yale University Chirag R. Parikh, Yale University School of Medicine Bingqing Zhou, Yale University 4h. Statistical Modeling of Gap Times in Presence of Panel Count Data with Intermittent Examination Times: An Application to Spontaneous Labor in Women Ling Ma* and Rajeshwari Sundaram, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 4i. Competing Risks Model of Screening and Symptoms Diagnosis for Prostate Cancer Sheng Qiu* and Alexander Tsodikov, University of Michigan 4j. Joint Modeling of Recurrent Event Processes and Intermittently Observed Time-Varying Binary Covariate Processes Shanshan Li*, Indiana University Richard M. Fairbanks School of Public Health, Indianapolis 4k. Composite Outcomes Versus Competing Risks Paul Kolm*, Christiana Care Health Systems

* = Presenter n = Student Award Winner Program 49 4l. Quantile Regression Models for Interval-Censored Failure Time Data Fang-Shu Ou*, Donglin Zeng and Jianwen Cai, University of North Carolina, Chapel Hill 4m. Empirical Likelihood Confidence Bands for the Difference of Survival Functions Under the Proportional Hazards Model Mai Zhou and Shihong Zhu*, University of Kentucky

5. POSTERS: Causal Inference Sponsor: ENAR 5a. INVITED POSTER: A Causal Framework for Meta Analyses Michael E. Sobel*, David Madigan and Wei Wang*, Columbia University 5b. The Principal Direction of Mediation Oliver Chen*, Elizabeth Ogburn, Ciprian Crainiceanu, Brian Caffo and Martin Lindquist, Johns Hopkins Bloomberg School of Public Health 5c. Dynamic Marginal Structural Models to Test the Benefit of Lung Transplantation Treatment Regimes Jeffrey A. Boatman* and David M. Vock, University of Minnesota 5d. A Model Based Approach for Predicting Principal Stratum Membership in Environmental Interventions Katherine E. Freeland*, Johns Hopkins Bloomberg School of Public Health 5e. Propensity Score Approach to Modeling Medical Cost Using Observational Data Jiaqi Li* and Nandita Mitra, University of Philadelphia Elizabeth Handorf, Fox Chase Cancer Center Justin Bekelman, University of Philadelphia 5f. Generalizing Evidence from Randomized Trials Using Inverse Probability of Selection Weights Ashley L. Buchanan*, Michael G. Hudgens and Stephen R. Cole, University of North Carolina, Chapel Hill 5g. Racial Disparities in Cancer Survival: A Causal Inference Perspective Linda Valeri*, Jarvis Chen, Nancy Krieger, Tyler J. VanderWeele and Brent A. Coull, Harvard School of Public Health

50 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 6. POSTERS: Statistical Genetics, GWAS, and ‘Omics Data Sponsor: ENAR 6a. A Data-Adaptive SNP-Set-Based Association Test of Longitudinal Traits Yang Yang* and Peng Wei, University of Texas Health Science Center at Houston Wei Pan, University of Minnesota 6b. Genetic Analysis of Data from Structured Populations Yogasudha Veturi* and Gustavo de los Campos, University of Alabama at Birmingham 6c. Mapping Disease Susceptibility Loci for Multiple Complex Traits with U-Statistics Ming Li*, University of Arkansas for Medical Sciences Changshuai Wei, University of North Texas Qing Lu, Michigan State University 6d. Permutation-Based Test Statistics for Intermediate Phenotypes in Genome-Wide Association Studies Wei Xue* and Eric Bair, University of North Carolina, Chapel Hill 6e. Statistics for Genetic Association in the Presence of Covariates — Genome Scanning Considerations Hui-Min Lin*, Eleanor Feingold and Yan Lin, University of Pittsburgh 6f. Power and Sample Size Determination for Time Course Microarray Differential Expression Studies: A False Discovery Rate and Permutation-Based Simulation Method Joanne C. Beer*, University of Pittsburgh Thuan Nguyen, Kemal Sonmez and Dongseok Choi, Oregon Health & Science University 6g. Functional Random Field Models for Association Analysis of Sequencing Data Xiaoxi Shen*, Michigan State University Ming Li, University of Arkansas for Medical Sciences Zihuai He, University of Michigan Qing Lu, Michigan State University 6h. Quantifying Uncertainty in the Identification of Proteins, Post-Translational Modifications (PTMs) and Proteoforms Naomi C. Brownstein* and Xibei Dang, Florida State University National High Magnetic Field Lab Eric Bair, University of North Carolina, Chapel Hill Nicolas L. Young, Florida State University National High Magnetic Field Lab 6i. A Statistical Pipeline for Studying Co-Regulated Genes Using Single-Cell RNA-Seq Data Ning Leng* and Li-Fang Chu, Morgridge Institute for Research Yuan Li, University of Wisconsin, Madison Peng Jiang, Chris Barry, Ron Stewart and James Thomson, Morgridge Institute for Research Christina Kendziorski, University of Wisconsin, Madison

* = Presenter n = Student Award Winner Program 51 6j. Outlier Detection for Quality Control in Flow Cytometry Using Compositional Data Analysis Kipper Fletez-Brant*, Johns Hopkins University Josef Spidlen and Ryan Brinkman, BC Cancer Agency Pratip Chattopadhyay, National Institutes of Health 6k. Power Analysis for Genome-Wide Association Study in Biomarker Discovery Wenfei Zhang*, Yuefeng Lu, Yang Zhao, Vincent Thuillier, Jeffrey Palmer, Sherry Cao, Jike Cui, Stephen Madden and Srinivas Shankara, Sanofi 6l. Differential Dynamics in Single-Cell RNA-Seq Experiments Keegan D. Korthauer* and Christina Kendziorski, University of Wisconsin, Madison 6m. Experimental Design for Bulk Single-Cell RNA-Seq Studies Rhonda L. Bacher* and Christina Kendziorski, University of Wisconsin, Madison 6n. A Hierarchical Mixture Model for Joint Prioritization of GWAS Results from Multiple Related Phenotypes Cong Li*, Yale University Can Yang, Hong Kong Baptist University Hongyu Zhao, Yale School of Public Health 6o. Nonparametric Tests for Differential Enrichment Analysis with Multi-Sample ChIP-Seq Data Qian Wu*, BioStat Solution Kyoung-Jae Won and Hongzhe Li, University of Pennsylvania 6p. Analysis of Mass Spectrometry Data and Preproccesing Methods for Metabolomics Leslie Myint* and Kasper Hansen, Johns Hopkins University 6q. INVITED POSTER: Accounting for Measurement Error in Genomic Data and Misclassification of Subtypes in the Analysis of Heterogeneous Tumor Data Daniel Nevo, Hebrew University, Jerusalem, Israel David Zucker*, Hebrew University, Jerusalem, Israel Molin Wang, Harvard School of Public Health Donna Spiegelman, Harvard School of Public Health

52 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 7. POSTERS: Methodology and Applications in Epidemiology, Environment, and Ecology Sponsor: ENAR 7a. INVITED POSTER: Carpe Diem! Biostatisticians Impacting the Conducting and Reporting of Clinical Studies Sally Morton*, University of Pittsburgh 7b. On Stratified Bivariate Ranked Set Sampling with Optimal Allocation for Naive and Ratio Estimators Lili Yu, Hani Samawi, Daniel Linder, Arpita Chatterjee, Yisong Huang* and Robert Vogel, Georgia Southern University 7c. Comparisons of the Cancer Risk Estimates between Excess Relative Risk and Relative Risk Models: A Case Study Shu-Yi Lin*, Taipei City Hospital, Taiwan 7d. A Regression Based Spatial Capture-Recapture Model for Estimating Species Density Purna S. Gamage*, Souparno Ghosh, Philip S. Gipson and Gregory Pavur, Texas Tech University 7e. Application of the Use of Percentage Difference from Median BMI to Overcome Ceiling Effects in Adiposity Change in Children Christa Lilly* and Lesley Cottrell, West Virginia University Karen Northrup and Richard Wittberg, Wood County School System 7f. A Multi-Pathogen Hierarchical Bayesian Model for Spatio-Temporal Transmission of Hand, Foot and Mouth Disease Xueying Tang*, Nikolay Bliznyuk, Yang Yang and Ira Longini, University of Florida 7g. Evaluating Risk-Prediction Models Using Data from Electronic Health Records Le Wang*, Pamela A. Shaw, Hansie Mathelier, Stephen E. Kimmel and Benjamin French, University of Pennsylvania 7h. A Bayesian Model for Identifying and Predicting the Spatio-Temporal Dynamics of Re-Emerging Urban Insect Infestations Erica Billig*, Michael Levy, Michelle Ross and Jason Roy, University of Pennsylvania 7i. Semi-Markov Models for Interval Censored Transient Cognitive States with Back Transitions and a Competing Risk Shaoceng Wei* and Richard Kryscio, University of Kentucky

* = Presenter n = Student Award Winner Program 53 7j. Growth Curves for Cystic Fibrosis Infants Vary in the Ability to Predict Lung Function Yumei Cao* and Raymond G. Hoffmann, Medical College of Wisconsin Evans M. Machogu, Indiana University School of Medicine Praveen S. Goday and Pippa M. Simpson, Medical College of Wisconsin 7k. An Examination of the Concept of Frailty in the Elderly Felicia R. Griffin*, Daniel L. McGee and Elizabeth H. Slate, Florida State University 7l. Efficiencies from Using Entire United States Responses in Predicting County Level Smoking Rates for West Virginia Using Publicly Available Data Dustin M. Long* and Emily A. Sasala, West Virginia University 7m. Optimally Combined Estimation for Tail Quantile Regression Kehui Wang*, North Carolina State University Huixia Judy Wang, The George Washington University

8. POSTERS: Variable Selection and Methods for High Dimensional Data Sponsor: ENAR 8a. Bayes Factor Consistency Under g-prior Linear Model with Growing Model Size Ruoxuan Xiang*, Malay Ghosh and Kshitij Khare, University of Florida 8b. Variable Selection for Cox Proportional Hazard Frailty Model Ioanna Pelagia* and Jianxin Pan, The University of Manchester, United Kingdom 8c. Fused Lasso Approach to Assessing Data Comparability with Applications in Missing Data Imputation Lu Tang* and Peter X.K. Song, University of Michigan 8d. Multiple Imputation Using Sparse PCA for High-Dimensional Data Domonique Watson Hodge* and Qi Long, Emory University 8e. Topic Modeling for Signal Detection of Safety Data from Adverse Event Reporting System Database Weizhong Zhao*, Wen Zou and James J. Chen, U.S. Food and Drug Administration 8f. Building Risk Models with Calibrated Margins Paige Maas*, National Cancer Institute, National Institutes of Health Yi-Hau Chen, Academia Sinica Raymond Carroll, Texas A&M University Nilanjan Chatterjee, National Cancer Institute, National Institutes of Health

54 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 8g. Categorical Predictors and Pairwise Comparisons in Logistic Regression via Penalization and Bregman Methods Tian Chen* and Howard Bondell, North Carolina State University 8h. Comparison of Step-Wise Variable Selection, BlmmLasso, and GMMBoost for Identification of Predictor Interactions Associated with Disease Outcome Yunyun Jiang* and Bethany Wolf, Medical University of South Carolina 8i. Shrinkage Priors for Bayesian Learning from High Dimesional Genetics Data Anjishnu Banerjee*, Medical College of Wisconsin 8j. Functional Principal Component Analysis to Fifty-Eight Most Traded Currencies Based on Euro Jong-Min Kim, University of Minnesota, Morris Ali H. AL-Marshadi, King Abdulaziz University Junho Lim*, University of Minnesota, Morris

9. POSTERS: Bayesian Methods and Computational Algorithms Sponsor: ENAR 9a. INVITED POSTER: Nonparametric Bayes Models for Modeling Longitudinal Change in Association among Categorical Variables Tsuyoshi Kunihama, Duke University Amy Herring*, University of North Carolina, Chapel Hill David Dunson, Duke University Carolyn Halpern, University of North Carolina, Chapel Hill 9b. Regression Model Estimation and Prediction Incorporating Coefficients Information Wenting Cheng*, Jeremy M.G. Taylor and Bhramar Mukherjee, University of Michigan 9c. Cross-Correlation of Change Point Problem Congjian Liu*, Georgia Southern University 9d. Bayesian Network Models for Subject-Level Inference Sayantan Banerjee*, Han Liang and Veerabhadran Baladandayuthapani, University of Texas MD Anderson Cancer Center 9e. Algorithms for Constrained Generalized Eigenvalue Problem Eun Jeong Min* and Hua Zhou, North Carolina State University

* = Presenter n = Student Award Winner Program 55 9f. CycloPs: A Cyclostationary Algorithm for Automatic Walking Recognition Jacek K. Urbanek* and Vadim Zipunnikov, Johns Hopkins Bloomberg School of Public Health Tamara B. Harris, National Institute on Aging, National Institutes of Health Nancy W. Glynn, University of Pittsburgh Ciprian Crainiceanu, Johns Hopkins Bloomberg School of Public Health Jaroslaw Harezlak, Indiana University School of Medicine 9g. Simulation-Based Estimation of Mean and Variance for Meta-Analysis via Approximate Bayesian Computation (ABC) Deukwoo Kwon* and Isildinha M. Reis, University of Miami 9h. The Effects of Sparsity Constraints on Inference of Biological Processes in Stochastic Non-Negative Matrix Factorization of Expression Data Wai S. Lee*, Alexander V. Favorov and Elana J. Fertig, Johns Hopkins University Michael F. Ochs, The College of New Jersey 9i. Bayesian Sample Size Determination for Hurdle Models Joyce Cheng*, David Kahle and John W. Seaman, Baylor University 9j. Fast Covariance Estimation for Sparse Functional/Longitudinal Data Luo Xiao*, Johns Hopkins University David Ruppert, Cornell University Vadim Zipunnikov and Ciprian Crainiceanu, Johns Hopkins Bloomberg School of Public Health 9k. Prior Elicitation for Logistic Regression with Data Exhibiting Markov Dependency Michelle S. Marcovitz* and John Seaman Jr., Baylor University

56 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner

MONDAY, MARCH 16

8:30 am – 10:15 am

10. Advances in Patient-Centered Outcomes (PCOR) Ashe Auditorium Methodology (3rd Floor) Sponsors: ENAR, ASA Biometrics Section, ASA Section on Statistics in Epidemiology Organizers: Qi Long, Emory University and Jason Gerson, Patient-Centered Outcomes Research Institute Chair: Qi Long, Emory University 8:30 PCORI Funding Opportunities for Biostatisticians Jason Gerson*, Patient-Centered Outcomes Research Institute (PCORI) 8:55 Causal Inference for Effectiveness Research in Using Secondary Data Sebastian Schneeweiss*, Harvard University 9:20 Optimal, Two Stage, Adaptive Enrichment Designs for Randomized Trials, Using Sparse Linear Programming Michael Rosenblum*, Johns Hopkins Bloomberg School of Public Health Xingyuan Fang and Han Liu, Princeton University 9:45 Treatment Effect Inferences Using Observational Data when Treatments Effects are Heterogeneous Across Outcomes: Simulation Evidence John M. Brooks* and Cole G. Chapman, University of South Carolina

10:10 Floor Discussion

58 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 11. Looking Under the Hood: Assumptions, Methods Brickell (Terrace Level) and Applications of Microsimulation Models to Inform Health Policy Sponsors: ENAR, ASA Section on Statistics in Epidemiology Organizer: Ann Zauber, Memorial Sloan Kettering Cancer Center Chair: Eric (Rocky) Feuer, National Cancer Institute, National Institutes of Health 8:30 Introduction to the CISNET Program and Population Comparative Modeling Eric J. Feuer*, National Cancer Institute, National Institutes of Health 8:50 Microsimulation Modeling to Inform Health Policy Decisions on Age to Begin, Age to End, and Intervals of Colorectal Cancer Screening Ann G. Zauber*, Memorial Sloan Kettering Cancer Center 9:10 Role of Calibration and Validation in Developing Microsimulation Models Carolyn M. Rutter*, RAND Corporation 9:30 Using Microsimulation to Assess the Relative Contributions of Screening and Treatment in Observed Reductions in Breast Cancer Mortality in the United States Donald A. Berry*, University of Texas MD Anderson Cancer Center 9:50 Synthesis of Randomized Controlled Trials of Prostate Cancer Screening to Assess Impact of PSA Testing Using Microsimulations Ruth Etzioni* and Roman Gulati, Fred Hutchinson Cancer Research Center Alex Tsodikov, University of Michigan Eveline Heijnsdijk and Harry de Koning, Erasmus University

10:10 Floor Discussion

* = Presenter n = Student Award Winner Program 59 12. Optimal Inference for HighDimensional Problems Miami Lecture Hall Sponsors: ENAR, ASA Biometrics Section (3rd Floor) Organizer: Jelena Bradic, University of California, San Diego Chair: Jelena Bradic, University of California, San Diego 8:30 A Non-Parametric Natural Image for Decoding Visual Stimuli from the Brain Yuval Benjamini*, Stanford University Bin Yu, University of California, Berkeley 8:55 Does lq Minimization Outperform l1 Minimization? Arian Maleki*, Columbia University 9:20 Inference in High-Dimensional Varying Coefficient Models Mladen Kolar*, University of Chicago Damian Kozbur, ETH, Zurich 9:45 Feature Augmentation via Nonparametrics and Selection (FANS) in High Dimensional Classification Jianqing Fan, Princeton University Yang Feng, Columbia University Jiancheng Jiang, University of North Carolina, Charlotte Xin Tong*, University of Southern California

10:10 Floor Discussion

13. Lifetime Data Analysis Highlights Johnson (3rd Floor) Sponsors: ENAR, ASA Biometrics Section, Lifetime Data Analysis Organizer: Mei-Ling Ting Lee, University of Maryland Chair: Ruth Pfeiffer, National Cancer Institute, National Institutes of Health 8:30 Modeling the “Win Ratio” in Clinical Trials with Multiple Outcomes David Oakes*, University of Rochester 8:55 A Model for Time to Fracture with a Shock Stream Superimposed on Progressive Degradation: The Study of Osteoporotic Fractures Xin He*, University of Maryland, College Park G. A. Whitmore, McGill University Geok Yan Loo, University of Maryland, College Park Marc C. Hochberg, University of Maryland, Baltimore Mei-Ling Ting Lee, University of Maryland, College Park

60 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 9:20 Joint Rate Models for Bivariate Recurrent Events with Frailty Processes Mei-Cheng Wang*, Johns Hopkins University 9:45 Efficient Estimation of the Cox Model with Auxiliary Landmark Time Survival Information Chiung-Yu Huang*, Johns Hopkins University Jing Qin, National Institute of Allergy and Infectious Diseases, National Institutes of Health Huei-Ting Tsai, Georgetown University

10:10 Floor Discussion

14. Recent Advances and Challenges in the Design Foster (3rd Floor) of Early Stage Cancer Trials Sponsors: ENAR, ASA Biopharmaceutical Section Organizer: Ken Cheung, Columbia University Chair: Ken Cheung, Columbia University 8:30 Motivating Sample Sizes in One- and Two-Agent Phase I Designs via Bayesian Posterior Credible Intervals Thomas M. Braun*, University of Michigan 8:55 Beyond the MTD: Personalized Medicine and Clinical Trial Design Daniel Normolle*, Brenda Diergaarde and Julie Bauman, University of Pittsburgh 9:20 Understanding the Toxicity Profile of Novel Anticancer Therapies Shing M. Lee*, Columbia University 9:45 Simple Benchmark for Planning and Evaluating Complex Dose Finding Designs Ken Cheung*, Columbia University

10:10 Floor Discussion

* = Presenter n = Student Award Winner Program 61 15. Large Scale Data Science for Observational Tuttle (Terrace Level) Healthcare Studies Sponsor: IMS Organizers: Marc Suchard, University of California, Los Angeles and David Madigan, Columbia University Chair: Martijn J. Schuemie, Johnson & Johnson 8:30 Honest Inference from Observational Database Studies David Madigan*, Columbia University 8:55 Interpretable Feature Creation and Model Uncertainty in Observational Medical Data Tyler McCormick*, and Rebecca Ferrell, University of Washington 9:20 Beyond Crude Cohort Designs: Pharmacoepidemiology at Scale Marc A. Suchard*, University of California, Los Angeles 9:45 Safety Analysis Strategies for Comparing Two Cohorts Selected from Healthcare Data using Propensity Scores William DuMouchel* and Rave Harpaz, Oracle Health Sciences

10:10 Floor Discussion

16. CONTRIBUTED PAPERS: Ibis (3rd Floor) Competing Risks Sponsor: ENAR Chair: Domonique Watson Hodge, Emory University 8:30 Extending Fine and Gray’s Model: General Approach for Competing Risks Analysis Anna Bellach*, University of Copenhagen and University of North Carolina, Chapel Hill Jason Peter Fine, University of North Carolina, Chapel Hill Ludger Rüschendorf, Albert Ludwigs University of Freiburg im Breisgau Michael R. Kosorok, University of North Carolina, Chapel Hill 8:45 Non-Parametric Cumulative Incidence Estimation Under Misclassification in the Cause of Failure Giorgos Bakoyannis*, Indiana University Menggang Yu, University of Wisconsin Constantin T. Yiannoutsos, Indiana University Constantine Frangakis, Johns Hopkins University

62 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 9:00 Efficient Estimation of Semiparametric Transformation Models for the Cumulative Incidence of Competing Risks Lu Mao n and Danyu Lin, University of North Carolina, Chapel Hill 9:15 Joint Dynamic Modeling of Recurrent Competing Risks and a Terminal Event Piaomu Liu* and Edsel Peña, University of South Carolina, Columbia 9:30 Dynamic Prediction of Subdistribution Functions for Data with Competing Risks Qing Liu* and Chung-Chou H. Chang, University of Pittsburgh 9:45 Competing Risks Regression using Pseudo-Values Under Random Signs Censoring Tianxiu Wang* and Chung-Chou H. Chang, University of Pittsburgh 10:00 Kernel Score Test for Progression Free Survival Matey Neykov* and Tianxi Cai, Harvard University

17. CONTRIBUTED PAPERS: Pearson I (3rd Level) Applications and Methods in Environmental Health Sponsor: ENAR Chair: Yang Yang, University of Texas Health Science Center at Houston 8:30 Methodology for Quantifying the Change in Mortality Associated with Future Ozone Exposures Under Climate Change Stacey E. Alexeeff*, Gabriele G. Pfister and Doug Nychka, National Center for Atmospheric Research 8:45 Estimation of Environmental Exposure Distribution Adjusting for Dependence between Exposure Level and Detection Limit Yuchen Yang*, Brent Shelton and Tom Tucker, University of Kentucky Li Li, Case Western Reserve University Richard Kryscio and Li Chen, University of Kentucky 9:00 Spatial Confounding, Spatial Scale and the Chronic Health Effects of Coarse Thoracic Particulate Matter Helen Powell* and Roger D. Peng, Johns Hopkins Bloomberg School of Public Health 9:15 Estimating the Causal Effect of Coal Burning Power Plants on CO2 Emissions Georgia Papadogeorgou*, Corwin Zigler and Francesca Dominici, Harvard School of Public Health 9:30 Temporal Aspects of Air Pollutant Measures in Epidemiologic Analysis: A Simulation Study Laura F. White* and Jeffrey Yu, Boston University Bernardo Beckerman and Michael Jerrett, University of California, Berkeley Patricia Coogan, Boston University

* = Presenter n = Student Award Winner Program 63 9:45 Bayesian Models for Multiple Outcomes in Domains with Application to the Seychelles Child Development Study Luo Xiao, Johns Hopkins Bloomberg School of Public Health Sally W. Thurston*, University of Rochester David Ruppert, Cornell University Tanzy M.T. Love and Philip W. Davidson, University of Rochester 10:00 Analysis of 26 Million Area VOC Observations for the Prediction of Personal THC Exposure Using Bayesian Modeling Caroline P. Groth*, University of Minnesota Sudipto Banerjee, University of California, Los Angeles Gurumurthy Ramachandran and Ian Reagen, University of Minnesota Richard Kwok, National Institute of Environmental Health Sciences, National Institutes of Health Aaron Blair, National Cancer Institute, National Institutes of Health Dale Sandler and Lawrence Engel, National Institute of Environmental Health Sciences, National Institutes of Health Mark Stenzel and Patricia Stewart, Stewart Exposure Assessments, LLC

18. CONTRIBUTED PAPERS: Orchid C (Terrace Level) Statistical Methods for Genomics Sponsor: ENAR Chair: Wenna Xi, The Ohio State University 8:30 Identification of Consistent Functional Modules Xiwei Chen*, David L. Tritchler, Jeffrey C. Miecznikowski and Daniel P. Gaile, State University of New York at Buffalo 8:45 A Mediation-Based Integrative Genomic Analysis of Lung Cancer Sheila Gaynor* and Xihong Lin, Harvard University 9:00 Nonparametric Failure Time Analysis with Genomic Applications Cheng Cheng*, St. Jude Children’s Research Hospital 9:15 An Omnibus Test for Differential Abundance Analysis of Microbiome Data Jun Chen*, Mayo Clinic, Rochester Emily King, Iowa State University Diane Grill and Karla Ballman, Mayo Clinic, Rochester

64 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 9:30 Sparse Analysis for High Dimensional Data with Application to Data Integration Sandra Addo Safo*, Emory University Jeongyoun Ahn, University of Georgia 9:45 Robust Inference of Chromosome 3D Structure Using Hi-C Chromatin Interaction Data Kai Wang* and Kai Tan, University of Iowa

10:00 Floor Discussion

19. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Spatial and Spatio-Temporal Methods and Applications Sponsor: ENAR Chair: Anjana Grandhi, New Jersey Institute of Technology 8:30 A Semiparametric Approach for Spatial Point Process with Geocoding Error in Case-Control studies Kun Xu* and Yongtao Guan, University of Miami 8:45 Semiparametric Nonseparable Spatial-Temporal Single Index Model Hamdy Fayez Farahat Mahmoud* and Inyoung Kim, Virginia Tech 9:00 Statistical Analysis of Feed-Forward Loops Arising from Aging Physiological Systems Jonathan (JJ) H. Diah*, Feiran Zhong and Arindam RoyChoudhury, Columbia University 9:15 Bayesian Computation for Log-Gaussian Cox Processes: A Comparative Analysis of Methods Ming Teng*, University of Michigan Farouk S. Nathoo, University of Victoria Timothy D. Johnson, University of Michigan 9:30 The Joint Asymptotics for Estimating the Smoothness Parameters of Bivariate Gaussian Random Process Yuzhen Zhou* and Yimin Xiao, Michigan State University 9:45 Covariance Tapering for Anisotropic Nonstationary Gaussian Random Fields with Application to Large Scale Spatial Data Sets Abolfazl Safikhani* and Yimin Xiao, Michigan State University 10:00 Dynamic Nearest Neighbor Gaussian Process Models for Large Spatio-Temporal Datasets Abhirup Datta*, University of Minnesota Sudipto Banerjee, University of California, Los Angeles Andrew O. Finley, Michigan State University

* = Presenter n = Student Award Winner Program 65 20. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Case Studies in Longitudinal Data Analysis Sponsor: ENAR Chair: Yajuan Si, University of Wisconsin-Madison 8:30 Using the Sigmoid Mixed Models for Longitudinal Cognitive Decline Ana W. Capuano*, Robert S. Wilson and Sue E. Leurgans, Rush University Medical Center Jeffrey D. Dawson, University of Iowa Donald Hedeker, University of Chicago 8:45 Short-Term Blood Pressure Variability over 24 hours Using Mixed-Effects Models Jamie M. Madden*, Xia Lee, Patricia M. Kearney and Anthony P. Fitzgerald, University College Cork, Ireland 9:00 A Longitudinal Modelling Case Study in Renal Medicine and an Associated R Package Ozgur Asar*, Lancaster University Peter J. Diggle, Lancaster University and University of Liverpool James Ritchie and Philip A. Kalra, University of Manchester 9:15 A Likelihood Ratio Test for Nested Proportions Yi-Fan Chen*, University of Illinois, Chicago Jonathan Yabes and Maria Brooks, University of Pittsburgh Sonia Singh, Royal Children’s Hospital Lisa Weissfeld, Statistics Collaborative Inc. 9:30 Bayesian Nonparametric Quantile Regression Models: An Application to a Fetal Growth Study with Ultrasound Measurements Sungduk Kim* and Paul S. Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 9:45 Modeling Repeated Labor Curves in Consecutive Pregnancies: Individualized Prediction of Labor Progression from Previous Pregnancy Data Olive D. Buhule* and Paul S. Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Alexander C. McLain, University of South Carolina Katherine Grantz, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 10:00 An Example of Unconstrained Model for Covariance Structure for Multivariate Longitudinal Data: Major League Baseball Batter’s Salary with the Weighted Offensive Average Chulmin Kim*, University of West Georgia

66 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 21. CONTRIBUTED PAPERS: Gautier (3rd Floor) Meta Analysis Sponsor: ENAR Chair: Joanne C. Beer, University of Pittsburgh 8:30 Meta-Analysis Sparse K-Means Framework for Disease Subtype Discovery When Combining Multiple Transcriptomic Studies Zhiguang Huo* and George Tseng, University of Pittsburgh 8:45 Meta Analysis: A Causal Framework, with Application to Randomized Studies of Vioxx Michael E. Sobel*, David Madigan and Wei Wang, Columbia University 9:00 A Bayesian Hierarchical Model for Network Meta-Analysis of Diagnostic Tests Xiaoye Ma n and Haitao Chu, University of Minnesota Yong Chen, University of Texas Health Science Center, Houston Joseph Ibrahim, University of North Carolina, Chapel Hill 9:15 Inference for Correlated Effect Sizes Using Multiple Univariate Meta-Analyses Yong Chen, Yi Cai* and Chuan Hong, University of Texas Health Science Center, Houston Dan Jackson, Cambridge Institute of Public Health 9:30 Detecting Outlying Studies in Meta-Regression Models Using a Forward Search Algorithm Dimitris Mavridis, University of Ioannina Irini Moustaki*, London School of Economics Melanie Wall, Columbia University Georgia Salanti, University of Ioannina 9:45 Comparing Multiple Imputation Methods for Systematically Missing Subject-Level Data David M. Kline*, Eloise E. Kaizar and Rebecca R. Andridge, The Ohio State University

10:00 Floor Discussion

* = Presenter n = Student Award Winner Program 67 22. CONTRIBUTED PAPERS: Stanford (3rd Floor) Semi-Parametric Methods Sponsor: ENAR Chair: Laura H. Gunn, Stetson University 8:30 Understanding Gaussian Process Fits Using an Approximate Form of the Restricted Likelihood Maitreyee Bose* and James S. Hodges, University of Minnesota 8:45 Mitigating Bias in Generalized Linear Mixed Models: The Case for Bayesian Nonparametrics Joseph L. Antonelli n, Sebastien Haneuse and Lorenzo Trippa, Harvard School of Public Health 9:00 An Estimated Likelihood Estimator by Extracting Auxiliary Information under Outcome Dependent Sample Design Wansuk Choi* and Haibo Zhou, University of North Carolina, Chapel Hill 9:15 Estimation, IID Representation and Inference for the Average Outcome Under Stochastic Intervention on Dependent Data Oleg Sofrygin* and Mark J. van der Laan, University of California, Berkeley 9:30 Empirical Likelihood-Based Inference for Partially Linear Models Haiyan Su*, Montclair State University

9:45 Bayesian Nonparametric Methods for Testing Shape Constraint for Longitudinal Data Yifang Li*, North Carolina State University Sujit Ghosh, North Carolina State University & Statistical and Applied Mathematical Sciences Institute 10:00 Hypothesis Testing in Semi-Parametric Discrete Choice Model Yifan Yang* and Mai Zhou, University of Kentucky

68 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner MONDAY, MARCH 16

Lower Promenade 10:15 – 10:30 pm — Refreshment Break with Our Exhibitors (Terrace Level)

10:30 am – 12:15 pm 23. Trends and Innovations in Clinical Trial Statistics: Tuttle (Terrace Level) “The Future ain’t What it Used to be” Sponsors: ENAR, ASA Biopharmaceutical Section Organizer: Olga Marchenko, Quintiles Chair: Olga Marchenko, Quintiles 10:30 “The Future Ain’t What it Used to be” (Yogi Berra). Have Statisticians Received the Memo? Nevine Zariffa*, AstraZeneca Pharmaceuticals 11:00 Panelists: Sara Hughes, GlaxoSmithKline Dominic Labriola, Bristol-Myers Squibb Lisa LaVange, U.S. Food and Drug Administration Shiferaw Mariam, Janssen R&D Jerry Schindler, Merck Venkat Sethuraman, Bristol-Myers Squibb Frank Shen, AbbVie Anastasios (Butch) Tsiatis, North Carolina State University

12:00 Floor Discussion

* = Presenter n = Student Award Winner Program 69 24. Causal Inference in HIV/AIDS Research Foster (3rd Floor) Sponsors: ENAR, ASA Section on Statistics in Epidemiology Organizer: Michael Hudgens, University of North Carolina, Chapel Hill Chair: Michael Hudgens, University of North Carolina, Chapel Hill 10:30 Representing Unmeasured Confounding in Causal Models for Observational Data Joseph W. Hogan*, Brown University Dylan Small, University of Pennsylvania 10:55 Inverse Probability of Censoring Weights under Missing Not at Random with Application to CD4 Outcomes in HIV-Positive Patients in Kenya Judith J. Lok*, Harvard School of Public Health Constantin T. Yiannoutsos, Indiana University Fairbanks School of Public Health Agnes Kiragga, Infectious Diseases Institute, Kampala, Uganda Ronald J. Bosch, Harvard School of Public Health 11:20 Doubly Robust Instrumental Variable Estimation for Outcome Missing Not at Random BaoLuo Sun*, Lan Liu, James Robins and Eric Tchetgen Tchetgen, Harvard School of Public Health 11:45 Estimating Prevention Efficacy Among Compliers in HIV Pre- Exposure Prophylaxis (PrEP) Trials James Dai* and Elizabeth Brown, Fred Hutchinson Cancer Research Center and University of Washington

12:10 Floor Discussion

25. Open Problems and New Directions Merrick II (3rd Floor) in Neuroimaging Research Sponsors: ENAR, ASA Mental Health Statistics Section, ASA Section on Statistics in Imaging Organizers: Hernando Ombao, University of California, Irvine and Martin Lindquist, Johns Hopkins University Chair: Timothy Johnson, University of Michigan 10:30 Problems in Structural Brain Imaging: Wavelets and Regressions on Non-Euclidean Manifolds Moo K. Chung*, University of Wisconsin-Madison 10:55 Open Problems and New Directions in Modeling Electroencephalograms Hernando Ombao*, University of California, Irvine

70 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 11:20 Open Problems and New Directions in functional Magnetic Resonance Imaging (fMRI) Martin A. Lindquist*, Johns Hopkins University 11:45 Empirical Bayes Methods Leveraging Heritability for Imaging Genetics Wesley Kurt Thompson*, University of California, San Diego

12:10 Floor Discussion

26. Statistical Methods for Understanding Whole Johnson (3rd Floor) Genome Sequencing Sponsors: ENAR, ASA Biometrics Section Organizer: Jeffrey Leek, Johns Hopkins University Chair: Ingo Ruczinski, Johns Hopkins University 10:30 Group Association Test Using a Hidden Markov Model for Sequencing Data Charles Kooperberg*, Yichen Cheng and James Y. Dai, Fred Hutchinson Cancer Research Center 10:55 Variant Calling and Batch Effects in Deep Whole-Genome Sequencing Data Margaret A. Taub*, Johns Hopkins University Suyash S. Shringarpure, Stanford University Rasika A. Mathias and Ingo Ruczinski, Johns Hopkins University Kathleen C. Barnes, Johns Hopkins University and The CAAPA Consortium 11:20 Flexible Probabilistic Modeling of Genetic Variation in Global Human Studies John Storey*, Princeton University 11:45 Allele Specific Expression to Identify Causal Functional QTLs Barbara Englehardt*, Princeton University

12:10 Floor Discussion

* = Presenter n = Student Award Winner Program 71 27. Doing Data Science: Straight Talk Brickell (3rd Floor) from the Frontline Sponsors: ENAR, ASA Statistical Programmers Section Organizer: Bhramar Mukherjee, University of Michigan Chair: Bhramar Mukherjee, University of Michigan 10:30 Doing Data Science Rachel Schutt*, Newscorp 11:00 Discussant: Sumanta Basu, University of California, Berkeley 11:30 Discussant: Beka Steorts, Carnegie Mellon University

12:00 Floor Discussion

28. IMS Medallion Lecture Ashe Auditorium Sponsor: IMS (3rd Floor) Organizer: Lurdes Y.T. Inoue, University of Washington Chair: Lurdes Y.T. Inoue, University of Washington 10:30 Uncertainty Quantification in Complex Simulation Models Using Ensemble Copula Coupling Tilmann Gneiting*, Heidelberg Institute for Theoretical Studies (HITS) and Karlsruhe Institute of Technology (KIT) Roman Schefzik, Heidelberg University Thordis L. Thorarinsdottir, Norwegian Computing Center

72 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 29. Panel Discussion: In Memory of Marvin Zelen: Miami Lecture Hall Past, Present and Future of Clinical Trials and (3rd Floor) Cancer Research Sponsor: ENAR Organizer: Xihong Lin, Harvard University Chair: Xihong Lin, Harvard University 10:30 Colin Begg, Memorial Sloan Kettering Cancer Center Ross Prentice, Fred Hutchison Cancer Center Victor De Gruttola, Harvard Chan School of Public Health

12:00 Floor Discussion

30. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Methods for Clustered Data and Applications Sponsor: ENAR Chair: Sung Won Han, New York University 10:30 Multivariate Modality Inference with Application on Flow Cytometry Yansong Cheng*, GlaxoSmithKline Surajit Ray, University of Glasgow 10:45 Estimation of the Prevalence of Disease Among Clusters Using Random Partial-Cluster Sampling Sarah J. Marks*, John S. Preisser, Anne E. Sanders and James D. Beck, University of North Carolina, Chapel Hill 11:00 Testing Homogeneity in a Contaminated Normal Model with Correlated Data Meng Qi* and Richard Charnigo, University of Kentucky 11:15 On the Use of Between-within Models to Adjust for Confounding due to Unmeasured Cluster-Level Covariates Babette A. Brumback* and Zhuangyu Cai, University of Florida 11:30 Estimating the Effects of Center Characteristics on Center Outcomes: A Symbolic Data Approach Jennifer Le-Rademacher*, Medical College of Wisconsin

* = Presenter n = Student Award Winner Program 73 11:45 A Robust and Flexible Method to Estimate Association for Sparse Clustered Data Lijia Wang* and John J. Hanfelt, Emory University

12:00 Floor Discussion

31. CONTRIBUTED PAPERS: Ibis (3rd Floor) GWAS Sponsor: ENAR Chair: Luis G. Neon-Novelo, University of Louisiana at Lafayette 10:30 Gene-Disease Associations via Sparse Simultaneous Signal Detection Sihai Dave Zhao*, University of Illinois at Urbana-Champaign Tony Cai and Hongzhe Li, University of Pennsylvania 10:45 Statistical Tests for the Detection of Shared Common Genetic Variants between Heterogeneous Diseases Based on GWAS Julie Kobie*, University of Pennsylvania Sihai Dave Zhao, University of Illinois at Urbana-Champaign Yun R. Li, Hakon Hakonarson and Hongzhe Li, University of Pennsylvania 11:00 Testing Class-Level Genetic Associations Using Single-Element Summary Statistics Jing Qian*, Eric Reed and Sara Nunez, University of Massachusetts, Amherst Rachel Ballentyne, Liming Qu and Muredach P. Reilly, University of Pennsylvania Andrea S. Foulkes, Mount Holyoke College 11:15 Set-Based Tests for Genetic Association in Longitudinal Studies Zihuai He*, Min Zhang, Seunggeun Lee and Jennifer A. Smith, University of Michigan Xiuqing Guo, Harbor-UCLA Medical Center Walter Palmas, Columbia University Sharon L.R. Kardia, Ana V. Diez Roux and Bhramar Mukherjee, University of Michigan

74 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 11:30 GPA: A Statistical Approach to Prioritizing GWAS Results by Integrating Pleiotropy and Annotation Dongjun Chung*, Medical University of South Carolina Can Yang, Hong Kong Baptist University Cong Li, Joel Gelernter and Hongyu Zhao, Yale University 11:45 Optimum Study Design for Detecting Imprinting and Maternal Effects Based on Partial Likelihood Fangyuan Zhang*, The Ohio State University Abbas Khalili, McGill University Shili Lin, The Ohio State University 12:00 Analysis of Genomic Data via Likelihood Ratio Test in Composite Kernel Machine Regression Ni Zhao* and Michael C. Wu, Fred Hutchinson Cancer Research Center

32. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Applications, Simulations and Methods in Causal Inference Sponsor: ENAR Chair: Luojun Wang, The Pennsylvania State University 10:30 Estimating the Fraction who Benefit from a Treatment, Using Randomized Trial Data Emily J. Huang* and Michael A. Rosenblum, Johns Hopkins University 10:45 Sensitivity Analyses in the Presence of Effect Modification in Observational Studies Jesse Y. Hsu*, Dylan S. Small and Paul R. Rosenbaum, University of Pennsylvania 11:00 The Causal Effect of Gene and Percentage of Trunk Fat Interaction on Physical Activity Taraneh Abarin*, Memorial University 11:15 A Simulation Study of a Multiply-Robust Approach for Causal Inference with Binary or Continuous Missing Covariates Jia Zhan*, Changyu Shen and Xiaochun Li, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health Lingling Li, Harvard Medical School and Harvard Pilgrim Health Care Institute

* = Presenter n = Student Award Winner Program 75 11:30 The Impact of Unmeasured Confounding in Observational Studies Zugui Zhang* and Paul Kolm, Christiana Care Health System 11:45 Flexible Models for Estimating Optimal Treatment Initiation Time for Survival Endpoints: Application to Timing of cART Initiation in HIV/TB Co-Infection Liangyuan Hu* and Joseph W. Hogan, Brown University 12:00 Double Robust Goodness-of-Fit Test of Coarse Structural Nested Mean Models with Application to Initiating HAART in HIV-Positive Patients Shu Yang* and Judith Lok, Harvard School of Public Health

33. CONTRIBUTED PAPERS: Gautier (3rd Floor) Adaptive Designs and Dynamic Treatment Regimes Sponsor: ENAR Chair: Xiaoqing Zhu, Michigan State University 10:30 A Bayesian Optimal Design in Two-Arm, Randomized Phase II Clinical Trials with Endpoints from Exponential Families Wei Jiang*, Jo A. Wick, Jianghua He, Jonathan D. Mahnken and Matthew S. Mayo, University of Kansas Medical Center 10:45 A Novel Method for Estimating Optimal Tree-Based Treatment Regimes in Randomized Clinical Trials Lisa L. Doove*, Katholieke Universiteit Leuven Elise Dusseldorp, Leiden University Katrijn Van Deun, Tilburg University Iven Van Mechelen, Katholieke Universiteit Leuven 11:00 Longitudinal Bayesian Adaptive Designs for the Promotion of more Ethical Two Armed Randomized Controlled Trials: A Novel Evaluation of Optimality Jo Wick*, University of Kansas Medical Center Scott M. Berry, Berry Consultants Byron Gajewski, Hung-Wen Yeh, Won Choi, Christina M. Pacheco and Christine Daley, University of Kansas Medical Center 11:15 Identifying a Set that Contains the Best Dynamic Treatment Regimes Ashkan Ertefaie*, University of Pennsylvania Tianshuang Wu and Inbal Nahum-Shani, University of Michigan Kevin Lynch, University of Pennsylvania 11:30 Optimal Dynamic Treatment Regimes for Treatment Initiation with Continuous Random Decision Points Yebin Tao* and Lu Wang, University of Michigan Haoda Fu, Eli Lilly and Company

76 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 11:45 Statistical Inference for the Mean Outcome Under a Possibly Non-Unique Optimal Treatment Strategy Alexander R. Luedtke* and Mark J. van der Laan, University of California, Berkeley 12:00 Sequential Advantage Selection for Optimal Treatment Regime Ailin Fan*, Wenbin Lu and Rui Song, North Carolina State University

34. CONTRIBUTED PAPERS: Stanford (3rd Floor) Survival Analysis and Cancer Applications Sponsor: ENAR Chair: James Lymp, Genentech 10:30 Regression Analysis of Informative Current Status Data Under Cure Rate Model Yeqian Liu*, University of Missouri, Columbia Tao Hu, Capital Normal University, China Jianguo Sun, University of Missouri, Columbia 10:45 The Historical Cox Model Jonathan E. Gellar*, Johns Hopkins Bloomberg School of Public Health Fabian Scheipl, LMU Munich Mei-Cheng Wang, Johns Hopkins Bloomberg School of Public Health Dale M. Needham, Johns Hopkins School of Medicine Ciprian M. Crainiceanu, Johns Hopkins Bloomberg School of Public Health 11:00 Bayesian Analysis of Survival Data Under Generalized Extreme Value Distribution with Application in Cure Rate Model Dooti Roy*, University of Connecticut Vivekananda Roy, Iowa State University Dipak Dey, University of Connecticut 11:15 Joint Semiparametric Time-to-Event Modeling of Cancer Onset and Diagnosis When Onset is Unobserved John D. Rice* and Alex Tsodikov, University of Michigan 11:30 A Multiple Imputation Approach for Semiparametric Cure Model with Interval Censored Data Jie Zhou*, Jiajia Zhang, Alexander C. McLain and Bo Cai, University of South Carolina, Columbia 11:45 A Flexible Parametric Cure Rate Model with Known Cure Time Paul W. Bernhardt*, Villanova University 12:00 Change-Point Proportional Hazards Model for Clustered Event Data Yu Deng*, Jianwen Cai and Donglin Zeng, University of North Carolina, Chapel Hill Jinying Zhao, Tulane University

* = Presenter n = Student Award Winner Program 77 35. INVITED AND CONTRIBUTED ORAL POSTERS: Jasmine (Terrace Level) Methods and Applications in High Dimensional Data and Machine Learning Sponsor: ENAR Chair: Sarah Ratcliff, University of Pennsylvania 35a. INVITED POSTER: Machine Learning Methods for Constructing Real-Time Treatment Policies in Mobile Health Susan Murphy* and Yanzhen Deng*, University of Michigan 35b. INVITED POSTER: Predicting Strokes Using Relational Random Forests Zach Shahn, Patrick Ryan and David Madigan*, Columbia University 35c. Network-Constrained Group LASSO for High Dimensional Multinomial Classification with Application to Cancer Subtype Prediction Xinyu Tian*, Stony Brook University Jun Chen, Mayo Clinic Xuefeng Wang, Stony Brook University 35d. Two Sample Mean Test in High Dimensional Compositional Data Yuanpei Cao*, University of Pennsylvania Wei Lin, Peking University Hongzhe Li, University of Pennsylvania 35e. Classifications Based on Active Set Selections Wen Zhou*, Colorado State University Stephen Vardeman, Huaiqing Wu and Max Morris, Iowa State University 35f. Application of a Graph Theory Algorithm in Soft Clustering Wenzhu Mowrey*, Albert Einstein College of Medicine George C. Tseng, University of Pittsburgh Lisa A. Weissfeld, Statistics Collaborative, Inc. 35g. Testing for the Presence of Clustering Erika S. Helgeson* and Eric Bair, University of North Carolina, Chapel Hill 35h. Variable Selection and Sufficient Dimension Reduction for High Dimensional Data Yeonhee Park* and Zhihua Su, University of Florida 35i. Variable Selection for Treatment Decisions with Scalar and Functional Covariates Adam Ciarleglio*, New York University School of Medicine Eva Petkova, New York University School of Medicine and Nathan S. Kline Institute for Psychiatric Research R. Todd Ogden, Columbia University Thaddeus Tarpey, Wright State University

78 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 35j. MOPM: Multi-Operator Prediction Model Based on High-Dimensional Features Hojin Yang*, Hongtu Zhu and Joseph G. Ibrahim, University of North Carolina, Chapel Hill 35k. Structured Sparse CCA for High Dimensional Data Integration Sandra Safo* and Qi Long, Emory University 35l. SPARC: Optimal Estimation and Asymptotic Inference Under Semiparametric Sparsity Yang Ning* and Han Liu, Princeton University 35m. Local-Aggregate Modeling for Big-Data via Distributed Optimization: Applications to Neuroimaging Yue Hu n, Rice University Genevera I. Allen, Rice University, Baylor College of Medicine and Texas Children’s Hospital 35n. Residual Weighted Learning for Estimating Individualized Treatment Rules Xin Zhou* and Michael R. Kosorok, University of North Carolina, Chapel Hill 35o. Integrative Multi-Omics Clustering for Disease Subtype Discovery by Sparse Overlapping Group Lasso and Tight Clustering SungHwan Kim n, YongSeok Park and George Tseng, University of Pittsburgh 35p. Identifying Predictive Markers for Personalized Treatment Selection Yuanyuan Shen* and Tianxi Cai, Harvard University

* = Presenter n = Student Award Winner Program 79 MONDAY, MARCH 16

12:15 – 1:30 pm — Roundtable Luncheons Monroe (Terrace Level)

1:45 – 3:30 pm 36. Recent Research in Adaptive Randomized Ashe Auditorium Trials with the Goal of Addressing Challenges (3rd Floor) in Regulatory Science Sponsors: ENAR, ASA Biopharmaceutical Section Organizer: Michael Rosenblum, Johns Hopkins University Chair: Michael Rosenblum, Johns Hopkins University 1:45 Adaptive Enrichment with Subpopulation Selection at Interim Sue-Jane Wang* and Hsien-Ming James Hung, U.S. Food and Drug Administration 2:10 Post-Trial Simulation of Type I Error for Demonstration of Control of Type I Error Scott M. Berry*, Berry Consultants 2:35 Bayesian Commensurate Prior Approaches for Pediatric and Rare Disease Clinical Trials Bradley P. Carlin* and Cynthia Basu, University of Minnesota Brian Hobbs, University of Texas MD Anderson Cancer Center 3:00 Identifying Subpopulations with the Largest Treatment Effect Iván Díaz* and Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health

3:25 Floor Discussion

80 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 37. Statistical Innovations in Functional Genomics Johnson (3rd Floor) and Population Health Sponsor: ENAR Organizers: Hua Tang, Stanford University and Lihong Qi, University of California, Davis Chair: Marc Coram, Stanford University 1:45 Quality Preserving Databases: Statistically Sound and Efficient Use of Public Databases for an Infinite Sequence of Tests Saharon Rosset*, Tel Aviv University Ehud Aharoni and Hani Neuvirth, IBM Research 2:05 Fused Lasso Additive Model Ashley Petersen*, Daniela Witten and Noah Simon, University of Washington 2:25 Imputing Transcriptome in Inaccessible Tissues in and Beyond the GTEx Project via RIMEE Jiebiao Wang, Dan Nicolae, Nancy Cox and Lin S. Chen*, University of Chicago 2:45 A Bayesian Method for the Detection of Long-Range Chromosomal Interactions in Hi-C Data Zheng Xu and Guosheng Zhang, University of North Carolina, Chapel Hill Fulai Jin, Ludwig Institute for Cancer Research Mengjie Chen and Patrick F. Sullivan, University of North Carolina, Chapel Hill Zhaohui Qin, Emory University Terrence S. Furey, University of North Carolina, Chapel Hill Ming Hu, New York University Yun Li*, University of North Carolina, Chapel Hill 3:05 Fine Mapping of Complex Trait Loci with Coalescent Methods in Large Case-Control Studies Ziqan Geng, University of Michigan Paul Scheet, University of Texas MD Andersen Cancer Center Sebastian Zöllner*, University of Michigan

3:25 Floor Discussion

* = Presenter n = Student Award Winner Program 81 38. Big Data: Issues in Biosciences Miami Lecture Hall Sponsors: ENAR, ICSA (3rd Floor) Organizers: Charmaine Dean, University of Western Ontario, Zhezhen Jin, Columbia University and Hongyu Zhao, Yale University Chair: Charmaine Dean, University of Western Ontario 1:45 Big Genomics Data Analytics Haiyan Huang* and Bin Yu, University of California, Berkeley 2:15 Recalculating the Relative Risks of Air Pollution to Account for Preferential Site Selection James V. Zidek*, University of British Columbia Gavin Shaddick, University of Bath 2:45 Functional Data Analysis for Quantifying Brain Connectivity Hans-Georg Mueller* and Alexander Petersen, University of California, Davis Owen Carmichael, Louisiana State University

3:15 Floor Discussion

39. Recent Advances in Statistical Ecology Foster (3rd Floor) Sponsor: ENAR Organizer: Mahlet Tadesse, Georgetown University Chair: Mahlet Tadesse, Georgetown University 1:45 Efficient Spatial and Spatio-Temporal False Discovery Rate Control Ali Arab*, Georgetown University 2:10 Mixture of Inhomogeneous Matrix Models for Species-Rich Ecosystems Frederic Mortier*, CIRAD — Tropical Forest Goods and Ecosystem Services Unit 2:35 Spatio-Temporal Modeling of Multiple Species Migration Flow Trevor Oswald* and Christopher K. Wikle, University of Missouri, Columbia 3:00 Statistical Modeling of Spatial Discrete and Continuous Data in Ecology Jun Zhu*, University of Wisconsin, Madison

3:25 Floor Discussion

82 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 40. New Analytical Issues in Current Brickell (Terrace Level) Epidemiology Studies of HIV and Other Sexually Transmitted Infections Sponsor: ENAR Organizer: Xiangrong Kong, Johns Hopkins University Chair: Kellie Archer, Virginia Commonwealth University 1:45 A Framework for Quantifying Risk Stratification from Diagnostic Tests: Application to HPV Testing in Cervical Cancer Screening Hormuzd Katki*, National Cancer Institute, National Institutes of Health 2:05 Combining Information to Estimate Adherence in Trials of Pre-Exposure Prophylaxis for HIV Prevention James Hughes*, University of Washington 2:25 Analysis of Longitudinal Multivariate Outcome Data from Couples Cohort Studies: Application to HPV Transmission Dynamics Xiangrong Kong*, Johns Hopkins University 2:45 Sample Size Methods for Estimating HIV Incidence from Cross-Sectional Surveys Jacob Moss Konikoff* and Ron Brookmeyer, University of California, Los Angeles 3:05 Development of Accurate Methods to Estimate HIV Incidence in Cross-Sectional Surveys Oliver B. Laeyendecker*, National Institute of Allergy and Infectious Diseases, National Institutes of Health

3:25 Floor Discussion ENAR2015

* = Presenter n = Student Award Winner Program 83 41. Statistical Advances and Challenges Tuttle (Terrace Level) in Mobile Health Sponsor: IMS Organizer: Susan Murphy, University of Michigan Chair: Elizabeth Sweeney, Johns Hopkins University 1:45 Supporting Health Management in Everyday Life with Mobile Technology Predrag Klasnja*, Susan A. Murphy and Ambuj Tewari, University of Michigan 2:10 Measuring Stress and Addictive Behaviors from Mobile Physiological Sensors Santosh Kumar*, University of Memphis Emre Ertin, The Ohio State University Mustafa al’Absi, University of Minnesota David Epstein and Kenzie Preston, National Institute on Drug Abuse, National Institutes of Health Annie Umbricht, Johns Hopkins University 2:35 Not Everybody, but Some People Move Like You Ciprian M. Crainiceanu*, Johns Hopkins Bloomberg School of Public Health 3:00 Micro-Randomized Trials and mHealth Peng Liao, Pedja Klasjna, Ambuj Tewari and Susan Murphy*, University of Michigan

3:25 Floor Discussion

42. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Survey Research Sponsor: ENAR Chair: Stacey E Alexeeff, National Center for Atmospheric Research 1:45 Ordinal Bayesian Instrument Development: New Kid on the Patient Reported Outcome Measures Block Lili Garrard*, University of Kansas Medical Center Larry R. Price, Texas State University Marjorie J. Bott, University of Kansas Byron J. Gajewski, University of Kansas Medical Center 2:00 Quantifying Parental History in Survey Data Rengyi Xu*, Sara B. DeMauro and Rui Feng, University of Pennsylvania 2:15 Bayesian Nonparametric Weighted Sampling Inference Yajuan Si*, University of Wisconsin, Madison Natesh S. Pillai, Harvard University Andrew Gelman, Columbia University

84 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 2:30 How to Best Compute Propensity Scores in Complex Samples in Relation to Survey Weights Keith W. Zirkle* and Adam P. Sima, Virginia Commonwealth University 2:45 Multiple Imputation of the Accelerometer Data in the National Health and Nutrition Examination Survey Benmei Liu*, Mandi Yu, Barry I. Graubard and Richard Troiano, National Cancer Institute, National Institutes of Health Nathaniel Schenker, National Center for Health Statistics, Centers for Disease Control and Prevention 3:00 Split Questionnaire Survey Design in the Longitudinal Setting Paul M. Imbriano* and Trivellore E. Raghunathan, University of Michigan

3:15 Floor Discussion

43. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Graphical Models Sponsor: ENAR Chair: Sheila Gaynor, Harvard University 1:45 Regression Analysis of Networked Data Yan Zhou n and Peter X.K. Song, University of Michigan 2:00 Integrative Analysis of Genetical Genomics Data Incorporating Network Structure Bin Gao* and Yuehua Cui, Michigan State University 2:15 Estimating a Graphical Intra-Class Correlation Coefficient (GICC) Using Multivariate Probit-Linear Mixed Models Chen Yue*, Shaojie Chen, Haris Sair, Raag Airan and Brian Caffo, Johns Hopkins University 2:30 Estimation of Directed Subnetworks in Ultra High Dimensional Data for Gene Network Problem Sung Won Han* and Hua (Judy) Zhong, New York University 2:45 Longitudinal Graphical Models: Optimal Estimation and Asymptotic Inference Quanquan Gu*, Yuan Cao, Yang Ning and Han Liu, Princeton University 3:00 Jointly Estimating Gaussian Graphical Models for Spatial and Temporal Data Zhixiang Lin* and Tao Wang, Yale University Can Yang, Hong Kong Baptist University Hongyu Zhao, Yale University

3:15 Floor Discussion

* = Presenter n = Student Award Winner Program 85 44. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Joint Models for Longitudinal and Survival Data Sponsor: ENAR Chair: Kun Xu, University of Miami 1:45 Joint Modeling of Bivariate Longitudinal and Bivariate Survival Data in Spouse Pairs Jia-Yuh Chen* and Stewart J. Anderson, University of Pittsburgh 2:00 Joint Model of Bivariate Survival Times and Longitudinal Data Ke Liu* and Ying Zhang, University of Iowa 2:15 Dynamic Prediction of Acute Graft-versus-Host Disease with Time-Dependent Covariates Yumeng Li* and Thomas M. Braun, University of Michigan 2:30 The Joint Modelling of Recurrent Events and Other Failure Time Events Luojun Wang* and Vernon M. Chinchilli, The Pennsylvania State University 2:45 A Bayesian Approach for Joint Modeling of Longitudinal Menstrual Cycle Length and Fecundity Kirsten J. Lum*, Johns Hopkins University and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Rajeshwari Sundaram and Germaine M. Buck Louis, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Thomas A. Louis, Johns Hopkins University and U.S. Census Bureau 3:00 Joint Analysis of Multiple Longitudinal Processes and Survival Data Measured on Nested Time-Scales Using Shared Parameter Models: An Application to Fecundity Data Rajeshwari Sundaram*, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Somak Chatterjee, George Washington University

3:15 Floor Discussion

86 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 45. CONTRIBUTED PAPERS: Gautier (3rd Floor) Functional Data Analysis Sponsor: ENAR Chair: Ana W. Capuano, Rush University Medical Center 1:45 Generalized Multilevel Function-on-Scalar Regression and Principal Component Analysis Jeff Goldsmith*, Columbia University Vadim Zipunnikov and Jennifer Schrack, Johns Hopkins University 2:00 Inference on Fixed Effects in Complex Functional Mixed Models So Young Park* and Ana-Maria Staicu, North Carolina State University Luo Xiao and Ciprian Crainiceanu, Johns Hopkins Bloomberg School of Public Health 2:15 Generalized Function-on-Function Regression Janet S. Kim*, Ana-Maria Staicu and Arnab Maity, North Carolina State University 2:30 Variable Selection in Function-on-Scalar Regression Yakuan Chen*, Todd Ogden and Jeff Goldsmith, Columbia University 2:45 Bayesian Adaptive Functional Models with Applications to Copy Number Data Bruce D. Bugbee*, Veera Baladandayuthapani and Jeffrey S. Morris, University of Texas MD Anderson Cancer Center 3:00 Functional Bilinear Regression with Matrix Covariates via Reproducing Kernel Hilbert Space with Applications in Neuroimaging Data Analysis Dong Wang, University of North Carolina, Chapel Hill Dan Yang*, Rutgers University Haipeng Shen and Hongtu Zhu, University of North Carolina, Chapel Hill 3:15 Simultaneous Confidence Bands for Derivatives of Dependent Functional Data Guanqun Cao*, Auburn University

* = Presenter n = Student Award Winner Program 87 46. CONTRIBUTED PAPERS: Ibis (3rd Floor) Methods in Causal Inference: Instrumental Variable, Propensity Scores and Matching Sponsor: ENAR Chair: Ozgur Asar, Lancaster University 1:45 Methods to Overcome Violations of an Instrumental Variable Assumption: Converting a Confounder into an Instrument Michelle Shardell*, National Institute on Aging, National Institutes of Health 2:00 Assessing Treatment Effect of Thiopurines on Crohn’s Disease from a UK Population-Based Study Using Propensity Score Matching Laura H. Gunn*, Stetson University Sukhdev Chatu, St. George’s University Hospital London Sonia Saxena and Azeem Majeed, Imperial College London Richard Pollok, St. George’s University Hospital London 2:15 Semiparametric Causal Inference in Matched Cohort Studies Edward H. Kennedy n and Dylan S. Small, University of Pennsylvania 2:30 Revisiting the Comparison of Covariate Adjusted Logistic Regression versus Propensity Score Methods with Few Events per Covariate Fang Xia*, Phillip J. Schulte and Laine Thomas, Duke University School of Medicine 2:45 Bayesian Latent Propensity Score Approach for Average Causal Effect Estimation Allowing Covariate Measurement Error Elande Baro*, Yi Huang and Anindya Roy, University of Maryland Baltimore County 3:00 Comparative Performance of Multivariate Matching Methods that Select a Subset of Observations Maria de los Angeles Resa* and Jose R. Zubizarreta, Columbia University 3:15 Improving Treatment Effect Estimation in the Presence of Treatment Delay through Triplet Matching Erinn M. Hade* and Bo Lu, The Ohio State University Hong Zhu, University of Texas Southwestern Medical Center

88 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 47. CONTRIBUTED PAPERS: Stanford (3rd Floor) Covariates Measured with Error Sponsor: ENAR Chair: Xiaoye Ma, University of Minnesota 1:45 Locally Efficient Semiparametric Estimators for Proportional Hazards Models with Measurement Error Yuhang Xu* and Yehua Li, Iowa State University Xiao Song, University of Georgia 2:00 Separating Variability in Practice Patterns from Statistical Error: An Opportunity for Quality Improvement Laine Thomas* and Phillip J. Schulte, Duke University 2:15 Goodness-of-Fit Testing of Error Distribution in Linear Errors-in-Variables Model Xiaoqing Zhu*, Michigan State University 2:30 Estimating Recurrence and Incidence of Preterm Birth in Consecutive Pregnancies Subject to Measurement Error in Gestation: A Novel Application of Hidden Markov Models Paul S. Albert*, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 2:45 Multi-State Model with Missing Continuous Covariate Wenjie Lou*, Richard J. Kryscio and Erin Abner, University of Kentucky 3:00 Weighted l1-Penalized Corrected Quantile Regression for High Dimensional Measurement Error Models Abhishek Kaul* and Hira L. Koul, Michigan State University

3:00 Floor Discussion

* = Presenter n = Student Award Winner Program 89 48. INVITED AND CONTRIBUTED ORAL POSTERS: Jasmine (Terrace Level) Clinical Trials Sponsor: ENAR Chair: Reneé Moore, North Carolina State University 48a. INVITED POSTER: Split-Sample Based and Multiple Imputation Estimation and Computation Methods for Meta-Analysis of Clinical Trial Data and Otherwise Hierarchical Data Geert Molenbergs*, Universiteit Hasselt Geert Verbeke, Katholieke Universiteit Leuven Michael G. Kenward, London School of Hygiene and Tropical Medicine Wim Van der Elst and Lisa Hermans, Universiteit Hasselt Vahid Nassiri, Katholieke Universiteit Leuven 48b. INVITED POSTER: Over-Parameterization in Adaptive Dose-Finding Studies John O’Quigley, Universite Pierre et Marie Curie Nolan A. Wages and Mark R. Conaway, University of Virginia Ken Cheung, Columbia University Ying Yuan, University of Texas MD Anderson Cancer Center Alexia Iasonos*, Memorial Sloan Kettering Cancer Center 48c. Improving Some Clinical Trials Inference by Using Ranked Axillary Covariate Hani Samawi*, Rajai Jabrah, Robert Vogel and Daniel Linder, Georgia Southern University 48d. Direct Estimation of the Mean Outcome on Treatment when Treatment Assignment and Discontinuation Compete Xin Lu*, Emory University Brent A. Johnson, University of Rochester 48e. Bayesian Interim Analysis Methods for Phase Ib Expansion Trials Enable Earlier Go/No-Go Decisions in Oncology Drug Development James Lymp*, Jane Fridlyand and Hsin-Ju Hsieh, Genentech Daniel Sabanes Bove and Somnath Sarkar, F. Hoffmann-La Roche 48f. Unified Additional Requirement in Consideration of Regional Approval for Multi-Regional Clinical Trials Zhaoyang Teng*, Boston University Yeh-Fong Chen, The George Washington University Mark Chang, AMAG Pharmaceuticals and Boston University 48g. Efficiencies of Bayesian Adaptive Platform Clinical Trials Ben Saville* and Scott Berry, Berry Consultants 48h. A Bayesian Semiparametric Model for Interval Censored Data with Monotone Splines Bin Zhang, Cincinnati Children’s Hospital Medical Center Yue Zhang*, University of Cincinnati

90 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 48i. Comprehensive Evaluation of Adaptive Designs for Phase I Oncology Clinical Trials Sheau-Chiann Chen*, Vanderbilt University Yunchan Chi, National Cheng Kung University Yu Shyr, Vanderbilt University 48j. Statistical Inference for Composite Outcomes Based on Prioritized Components Ionut Bebu* and John M. Lachin, The George Washington University 48k. The Impact of Covariate Misclassification Using Generalized Linear Regression Under Covariate-Adaptive Randomization Liqiong Fan* and Sharon D. Yeatts, Medical University of South Carolina 48l. Non-Inferiority Test Based on Transformations Santu Ghosh*, Wayne State University Arpita Chatterjee, Georgia Southern University Samiran Ghosh, Wayne State University 48m. Methods Accounting for Mortality and Missing Data in Randomized Trials with Longitudinal Outcomes Elizabeth A. Colantuoni*, Johns Hopkins Bloomberg School of Public Health Chenguang Wang, Johns Hopkins School of Medicine Daniel O. Scharfstein, Johns Hopkins Bloomberg School of Public Health 48n. A Semiparametric Bayesian Approach Using Historical Control Data for Assessing Non-Inferiority in Three Arm Trials Arpita Chatterjee*, Georgia Southern University Santu Ghosh and Samiran Ghosh, Wayne State University 48o. Design Parameters and Effect of the Delayed-Start Design in Alzheimer’s Disease Guoqiao Wang* and Richard E. Kennedy, University of Alabama, Birmingham Lon S. Schneider, University of Southern California Gary R. Cutter, University of Alabama, Birmingham

* = Presenter n = Student Award Winner Program 91 MONDAY, MARCH 16

Lower Promenade 3:30 – 3:45 pm — Refreshment Break with Our Exhibitors (Terrace Level)

3:45 – 5:30 pm 49. CENS Invited Session — Careers in Statistics: Ashe Auditorium (3rd Floor) Skills for Success Sponsor: ENAR Organizer: Vivian Shih, AstraZeneca Chair: Michael McIsaac, Queen’s University 3:45 How to be Successful in Oral and Written Communications as a Biostatistician Peter Grant Mesenbrink*, Novartis Pharmaceuticals Corporation 4:15 Navigating the Academic Jungle Without Going Bananas Amy H. Herring*, University of North Carolina, Chapel Hill 4:45 What am I Going to be When I Grow Up? Evolving as a Statistician Nancy L. Geller*, National Heart, Lung and Blood Institute, National Institutes of Health

5:15 Floor Discussion

50. Analysis Methods for Data Obtained from Tuttle (Terrace Level) Electronic Health Records Sponsors: ENAR, ASA Biometrics Section, ASA Section on Statistics in Epidemiology Organizer: Sebastian Haneuse, Harvard University Chair: Sebastian Haneuse, Harvard University 3:45 Improving the Power of Genetic Association Tests with Imperfect Phenotype Derived from Electronic Medical Records Jennifer A. Sinnott* and Wei Dai, Harvard School of Public Health Katherine P. Liao and Elizabeth W. Karlson, Brigham and Women’s Hospital Isaac Kohane, Harvard Medical School Robert Plenge, Merck Research Laboratories Tianxi Cai, Harvard School of Public Health

92 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 4:15 Nonparametric Estimation of Patient Prognosis with Application to Electronic Health Records Patrick J. Heagerty* and Alison E. Kosel, University of Washington 4:45 Mining EHR Narratives for Clinical Research Enedia Mendonca*, University of Wisconsin, Madison

5:15 Floor Discussion

51. Statistical Challenges of Survey and Surveillance Foster (3rd Floor) Data in US Government Sponsors: ENAR, ASA Section on Statistics in Defense and National Security, ASA Survey Research and Methodology Section Organizer: Simone Gray, Centers for Disease Control and Prevention Chair: Simone Gray, Centers for Disease Control and Prevention 3:45 Using Venue-Based Sampling to Recruit Hard-to-Reach Populations Maria Corazon B. Mendoza*, Chris Johnson, Brooke Hoots and Teresa Finlayson, Centers for Disease Control and Prevention 4:10 Development of Guidelines for the Presentation of Data from the National Health and Nutrition Examination Survey Margaret Devers Carroll*, National Health and Nutrition Examination Survey, Centers for Disease Control and Prevention 4:35 Data Swapping Methods for Statistical Disclosure Limitation Guangyu Zhang*, Joe Fred Gonzalez, Anna Oganyan and Alena Maze, National Center for Health Statistics, Centers for Disease Control and Prevention 5:00 Practical Approaches to Design and Inference Through the Integration of Complex Survey Data and Non-Survey Information Sources John L. Eltinge*, U.S. Bureau of Labor Statistics Rachel M. Harter, RTI International

5:25 Floor Discussion

* = Presenter n = Student Award Winner Program 93 52. Reconstructing the Genomic Landscape Johnson (3rd Floor) from High-Throughput Data Sponsors: ENAR, ASA Biometric Section Organizers: Adam Olshen, University of California, San Francisco and Ronglai Shen, Memorial Sloan Kettering Cancer Center Chair: Adam Olshen, University of California, San Francisco 3:45 Copy Numbers in Circulating Tumor Cells (CTCs) Using DNA-Seq Henrik Bengtsson*, University of California, San Francisco 4:10 DNA Copy Number Analyses for Family Based Designs Ingo Ruczinski*, Johns Hopkins University 4:35 Reconstructing 3-D Genome Configurations: How and Why Mark Robert Segal*, University of California, San Francisco 5:00 A Latent Variable Approach for Integrative Clustering of Multiple Genomic Data Types Ronglai Shen*, Memorial Sloan-Kettering Cancer Center

5:25 Floor Discussion

53. Statistical Methods for Single Molecule Miami Lecture Hall (3rd Floor) Experiments Sponsors: ENAR, ASA Biometric Section Organizer: Ying Hung, Rutgers University Chair: Ying Hung, Rutgers University 3:45 Walking, Sliding, and Detaching: Time Series Analysis for Cellular Transport in Axons John Fricks*, Jason Bernstein and William Hancock, The Pennsylvania State University 4:10 Analyzing Single-Molecule Protein-Targeting Experiments via Hierarchical Models Samuel Kou* and Yang Chen, Harvard University 4:35 Bimolecular Reaction, Data Types, and an Alternative Model to the Smoluchowski Theory Hong Qian*, University of Washington 5:00 Hidden Markov Models with Applications in Cell Adhesion Experiments Jeff C. F. Wu, Georgia Institute of Technology Ying Hung*, Rutgers University

5:25 Floor Discussion

94 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 54. Subgroup Analysis and Adaptive Trials Brickell (Terrace Level) Sponsor: IMS Organizer: Donatello Telesca, University of California, Los Angeles Chair: Donatello Telesca, University of California, Los Angeles 3:45 A Bayes Rule for Subgroup Reporting — Bayesian Adaptive Enrichment Designs Peter Mueller*, University of Texas, Austin 4:15 Subgroup-Based Adaptive (SUBA) Designs for Multi-Arm Biomarker Trials Yanxun Xu, University of Texas, Austin Lorenzo Trippa, Harvard University Peter Mueller, University of Texas, Austin Yuan Ji*, NorthShore University HealthSystem and University of Chicago 4:45 Detection of Cancer Subgroup Associated Alternative Splicing Jianhua Hu*, University of Texas MD Anderson Cancer Center Xuming He, University of Michigan

5:15 Floor Discussion

55. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Methods to Assess Agreement Sponsor: ENAR Chair: Yansong Cheng, GlaxoSmithKline 3:45 Kappa Statistics for Correlated Matched-Pair Categorical Data Zhao Yang*, University of Tennessee Health Science Center Ming Zhou, Bristol-Myers Squibb 4:00 Sample Size Methods for Constructing Confidence Intervals for the Intra-Class Correlation Coefficient Kevin K. Dobbin* and Alexei C. Ionan, University of Georgia 4:15 Statistical Methods for Assessing Reproducibility in Multicenter Neuroimaging Studies Tian Dai* and Ying Guo, Emory University 4:30 Nonparametric Regression of Agreement Measure Between Ordinal and Continuous Outcomes AKM F. Rahman*, Limin Peng, Ying Guo and Amita Manatunga, Emory University

* = Presenter n = Student Award Winner Program 95 4:45 Inter-Observer Agreement for a Mixture of Data Types Shasha Bai*, University of Arkansas for Medical Sciences Marcelo A. Lopetegui, The Ohio State University 5:00 Assessing Reproducibility of Discrete and Truncated Rank Lists in High-Throughput Studies Qunhua Li*, The Pennsylvania State University 5:15 Exponentiated Lindley Poisson Distribution Mavis Pararai* and Gayan Liyanag, Indiana University of Pennsylvania Broderick Oluyede, Georgia Southern University

56. CONTRIBUTED PAPERS: Stanford (3rd Floor) Methylation and RNA Data Analysis Sponsor: ENAR Chair: Babette A Brumback, University of Florida 3:45 Identify Differential Alternative Splicing Events from Paired RNA-Seq Data Cheng Jia* and Mingyao Li, University of Pennsylvania 4:00 Functional Normalization of 450k Methylation Array Data Improves Replication in Large Cancer Studies Jean-Philippe Fortin n, Johns Hopkins Bloomberg School of Public Health Aurelie Labbe, McGill University Mathieu Lemire, Ontario Institute of Cancer Research Brent W. Zanke, Ottawa Hospital Research Institute Thomas J. Hudson, Ontario Institute of Cancer Research Elana J. Fertig, Johns Hopkins School of Medicine Celia M. T. Greenwood, Jewish General Hospital Montreal Kasper D. Hansen, Johns Hopkins Bloomberg School of Public Health 4:15 Detecting Differentially Methylated Regions (DMRs) by Mixed-Effect Logistic Model Fengjiao Hu* and Hongyan Xu, Georgia Regents University 4:30 Penalized Modeling for Variable Selection and Association Study of High-Dimensional MicroRNA Data with Repeated Measures Zhe Fei*, University of Michigan Yinan Zheng, Northwestern University Wei Zhang, University of Illinois, Chicago Justin B. Starren and Lei Liu, Northwestern University Andrea A. Baccarelli, Harvard School of Public Health Yi Li, University of Michigan Lifang Hou, Northwestern University

96 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 4:45 Comparison of Paired Tumor-Normal Methods for Differential Expression Analysis of RNA-Seq Data Janelle R. Noel*, Alice Wang, Rama Raghavan and Prabhakar Chalise, University of Kansas Medical Center Byunggil Yoo, Childrens Mercy Hospital Kansas City Sumedha Gunewardena, Kansas Intellectual and Developmental Disabilities Research Center Jeremy Chien and Brooke L. Fridley, University of Kansas Medical Center 5:00 Detecting Differential Alternative Splicing with Biological Replicates between Two Groups from RNA-Seq Data Yu Hu*, Cheng Jia, Dwight Stambolian and Mingyao Li, University of Pennsylvania 5:15 Functional Region-Based Test for DNA Methylation Kuan-Chieh Huang* and Yun Li, University of North Carolina, Chapel Hill

57. CONTRIBUTED PAPERS: Ibis (3rd Floor) New Developments in Imaging Sponsor: ENAR Chair: Sihai Dave Zhao, University of Illinois 3:45 Estimating Dynamics of Whole-Brain Functional Connectivity in Resting-State fMRI by Factor Stochastic Volatility Model Chee-Ming Ting*, Universiti Teknologi Malaysia, Malaysia Hernando Ombao, University of California, Irvine Sh-Hussain Salleh, Universiti Teknologi Malaysia, Malaysia 4:00 Kernel Smoothing GEE for Longitudinal fMRI Studies Yu Chen*, Min Zhang and Timothy D. Johnson, University of Michigan 4:15 A Hierarchical Bayesian Model for Studying the Impact of Stroke on Brain Motor Function Zhe Yu*, University of California, Irvine Raquel Prado, University of California, Santa Cruz Erin Burke Quinlan, Steven C. Cramer and Hernando Ombao, University of California, Irvine 4:30 Source Estimation for Multi-Trial Multi-Channel EEG Signals: A Statistical Approach Yuxiao Wang* and Hernando Ombao, University of California, Irvine Raquel Prado, University of California, Santa Cruz 4:45 An Exploratory Data Analysis of EEGs Time Series: A Functional Boxplots Approach Duy Ngo* and Hernando Ombao, University of California, Irvine Marc G. Genton and Ying Sun, King Abdullah University of Science and Technology

* = Presenter n = Student Award Winner Program 97 5:00 A Bayesian Functional Linear Cox Regression Model (BFLCRM) for Predicting Time to Conversion to Alzheimer’s Disease Eunjee Lee n, Hongtu Zhu and Dehan Kong, University of North Carolina, Chapel Hill Yalin Wang, Arizona State University Kelly Sullivan Giovanello and Joseph Ibrahim, University of North Carolina, Chapel Hill

5:00 Floor Discussion

58. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Latent Variable and Principal Component Models Sponsor: ENAR Chair: Jesse Y Hsu, University of Pennsylvania 3:45 A Latent Variable Model for Analyzing Correlated Ordered Categorical Data Ali Reza Fotouhi*, University of The Fraser Valley 4:00 Estimation of Branching Curves in the Presence of Subject Specific Random Effects Angelo Elmi*, The George Washington University Sarah J. Ratcliffe and Wensheng Guo, University of Pennsylvania 4:15 Composite Large Margin Classifiers with Latent Subclasses for Heterogeneous Biomedical Data Guanhua Chen n, Vanderbilt University Yufeng Liu and Michael R. Kosorok, University of North Carolina, Chapel Hill 4:30 Evaluation of Covariate-Specific Accuracy of Biomarkers without a Gold Standard Zheyu Wang*, Johns Hopkins University Xiao-Hua Zhou, University of Washington 4:45 Linear Mixed Model with Unobserved Informative Cluster Size: Application to a Repeated Pregnancy Study Ashok K. Chaurasia*, Danping Liu and Paul S. Albert, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 5:00 A Semiparametric Model of Estimating Non-Constant Factor Loadings Zhenzhen Zhang* and Brisa Sanchez, University of Michigan 5:15 Nested Partially-Latent Class Models (npLCM) for Estimating Disease Etiology in Case-Control Studies Zhenke Wu* and Scott L. Zeger, Johns Hopkins University

98 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 59. CONTRIBUTED PAPERS: Gautier (3rd Floor) Developments and Applications of Clustering, Classification, and Dimension Reduction Methods Sponsor: ENAR Chair: Taraneh Abarin, Memorial University 3:45 Separable Spatio-Temporal Principal Component Analysis Lei Huang n, Johns Hopkins University Philip T. Reiss, New York University School of Medicine Luo Xiao, Vadim Zipunnikov, Martin A. Lindquist and Ciprian Crainiceanu, Johns Hopkins University 4:00 Penalized Clustering Using a Hidden Markov Random Field Model: Detecting State-Related Changes in Brain Connectivity Yuting Xu* and Martin Lindquist, Johns Hopkins University 4:15 Clustering of Brain Signals Using the Total Variation Distance Carolina Euán*, Centro de Investigación en Matemáticas (CIMAT), A.C. Hernando Ombao, University of California, Irvine Joaquin Ortega, Centro de Investigación en Matemáticas (CIMAT), A.C. Pedro Alvarez-Esteban, Universidad de Valladolid, Spain 4:30 Impact of Data Reduction on Accelerometer Data in Children Daniela Sotres-Alvarez* and Yu Deng, University of North Carolina, Chapel Hill Guadalupe X. Ayala, San Diego State University Mercedes Carnethon, Northwestern University Alan M. Delamater, University of Miami Carmen R. Isasi, Albert Einstein College of Medicine Sonia Davis and Kelly R. Evenson, University of North Carolina, Chapel Hill 4:45 Learning Logic Rules for Disease Classification: With an Application to Developing Criteria Sets for the Diagnostic and Statistical Manual of Mental Disorders Christine M. Mauro n, Columbia University Donglin Zeng, University of North Carolina, Chapel Hill M. Katherine Shear and Yuanjia Wang, Columbia University 5:00 Characterizing Types of Physical Activity: An Unsupervised Way Jiawei Bai*, Luo Xiao, Vadim Zipunnikov and Ciprian M. Crainiceanu, Johns Hopkins University 5:15 Simultaneous Model-Based Clustering and Variable Selection: Extension to Mixed-Distribution Data Katie Evans, Dupont Tanzy M.T. Love* and Sally W. Thurston, University of Rochester

* = Presenter n = Student Award Winner Program 99 60. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Survival Analysis: Methods Development and Applications Sponsor: ENAR Chair: Jo Wick, University of Kansas Medical Center 3:45 Predictive Model and Dynamic Prediction for Recurrent Events with Dependent Termination Li-An Lin*, Sheng Luo and Barry Davis, University of Texas Health Sciences Center at Houston 4:00 An Extended Self-Triggering Model for Recurrent Event Data Jung In Kim*, Feng-Chang Lin and Jason Fine, University of North Carolina, Chapel Hill 4:15 A Pairwise-Likelihood Augmented Estimator for the Cox Model Under Left-Truncation Fan Wu* and Sehee Kim, University of Michigan Jing Qin, National Institute of Allergy and Infectious Diseases, National Institutes of Health Yi Li, University of Michigan 4:30 Rank-Based Testing Based on Cross-Sectional Survival Data with or without Prospective Follow-Up Kwun Chuen Gary Chan*, University of Washington Jing Qin, National Institute of Allergy and Infectious Diseases, National Institutes of Health 4:45 Computation Efficient Models for Fitting Large-Scale Survival Data Kevin He*, Yanming Li, Ji Zhu and Yi Li, University of Michigan 5:00 Multiple Imputation for Interval Censored Data with Time-Dependent Auxiliary Variables Using Incident and Prevalent Cohort Data Wen Ye* and Douglas Schaubel, University of Michigan 5:15 Model Flexibility for Regression Analysis of Survival Data with Informative Interval Censoring Tyler Cook* and Jianguo Sun, University of Missouri, Columbia

100 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 61. INVITED AND CONTRIBUTED ORAL POSTERS: Jasmine (Terrace Level) GWAS and Meta Analysis of Genetic Studies Sponsor: ENAR Chair: Mary Sammel, University of Pennsylvania 61a. INVITED POSTER: Hypothesis Testing for Sparse Signals in Genetic Association Studies Xihong Lin*, Harvard University 61b. INVITED POSTER: Meta-Analysis of Gene-Environment Interaction in Case-Control Studies by Adaptively Using Gene-Environment Correlation Bhramar Mukherjee*, Shi Li, John D. Rice, Jeremy MG Taylor, Heather Stringham and Michael L. Boehnke, University of Michigan 61c. Partial Linear Varying Index Coefficient Model for Gene-Environment Interactions Xu Liu* and Yuehua Cui, Michigan State University 61d. Tree-Based Model Averaging Approaches for Modeling Rare Variant Association in Case-Control Studies Brandon J. Coombes* and Saonli Basu, University of Minnesota Sharmistha Guha, Fair Isaac Corporation Nicholas Schork, J. Craig Venter Institute 61e. A Functional Approach to Association Testing of Multiple Phenotypes in Sequencing Studies Sneha Jadhav* and Qing Lu, Michigan State University 61f. Analysis of Sequence Data Under Multivariate Trait-Dependent Sampling Ran Tao*, Donglin Zeng, Nora Franceschini and Kari E. North, University of North Carolina, Chapel Hill Eric Boerwinkle, University of Texas Health Science Center Dan-Yu Lin, University of North Carolina, Chapel Hill 61g. Meta-Analysis of Complex Diseases at Gene Level by Generalized Functional Linear Models Ruzong Fan* and Yifan Wang, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Haobo Ren, Regeneron Pharmaceuticals, Inc. Yun Li, University of North Carolina, Chapel Hill Christopher Amos, Dartmouth Medical School Wei Chen, University of Pittsburgh Momiao Xiong, University of Texas, Houston Jason Moore, Dartmouth Medical School

* = Presenter n = Student Award Winner Program 101 61h. Gene Level Meta-Analysis of Quantitative Traits by Functional Linear Models Yifan Wang* and Ruzong Fan, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Michael Boehnke, University of Michigan Wei Chen, University of Pittsburgh Yun Li, University of North Carolina, Chapel Hill Momiao Xiong, University of Texas, Houston 61i. A New Estimating Equation Approach for Secondary Trait Analyses in Genetic Case-Control Studies Xiaoyu Song*, Iuliana Ionita-Laza and Ying Wei, Columbia University 61j. Novel Statistical Model for GWAS Meta-Analysis and Its Application to Trans-Ethic Meta-Analysis Jingchunzi Shi* and Seunggeun Lee, University of Michigan 61k. Multiple Phenotype Association Testing Based on Summary Statistics in Genome-Wide Association Studies Zhonghua Liu* and Xihong Lin, Harvard School of Public Health 61l. A New Approach for Detecting Gene-by-Gene Interactions Through Meta-Analyses Yulun Liu*, University of Texas, Health Science Center at Houston Paul Scheet, University of Texas MD Anderson Cancer Center Yong Chen, University of Texas, Health Science Center at Houston 61m. Genome-Wide Association Studies for Functional Valued Traits Han Hao* and Rongling Wu, The Pennsylvania State University 61n. Kernel-Based Testing for Nonlinear Effect of a SNP-Set under Multiple Candidate Kernels Tao He*, Ping-Shou Zhong and Yuehua Cui, Michigan State University 61o. A General Framework of Gene-Based Association Tests for Correlated Case-Control Samples Han Chen*, Chaolong Wang and Xihong Lin, Harvard School of Public Health 61p. Algorithm to Compute the Identity Coefficients at a Particular Locus Given the Marker Information J Concepcion Loredo-Osti* and Haiyan Yang, Memorial University 61q. Estimating the Empirical Null Distribution of Maxmean Statistics in Gene Set Analysis Xing Ren* and Jeffrey Miecznikowski, University at Buffalo, SUNY Song Liu and Jianmin Wang, Roswell Park Cancer Institute 61r. USAT: A Unified Score-Based Association Test for Multiple Phenotype-Genotype Analysis Debashree Ray* and Saonli Basu, University of Minnesota

102 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner TUESDAY, MARCH 17

8:30 – 10:15 am 62. Statistical Inference with Random Forests and Hibiscus B (Terrace Level) Related Ensemble Methods Sponsor: ENAR Organizer: Giles Hooker, Cornell University Chair: Giles Hooker, Cornell University 8:30 Consistency of Random Forests Gerard Biau*, Erwan Scornet and Jean-Philippe Vert, Pierre and Marie Curie University 8:55 Asymptotic Theory for Random Forests Stefan Wager*, Stanford Universityy 9:20 Detecting Feature Interactions in Bagged Trees and Random Forests Lucas K. Mentch* and Giles Hooker, Cornell University 9:45 Variable Selection with Bayesian Additive Regression Trees Shane T. Jensen*, Justin Bleich, Adam Kapelner and Edward I. George, University of Pennsylvania

10:10 Floor Discussion

63. Mediation and Interaction: Ashe Auditorium (3rd Floor) Theory, Practice and Future Directions Sponsors: ENAR, ASA Biometrics Section, ASA Section on Statistics in Epidemiology Organizers: Brisa Sanchez, University of Michigan and Melody Goodman, Washington University in St. Louis Chair: Brisa Sanchez, University of Michigan 8:30 A Unification of Mediation and Interaction: A Four-Way Decomposition Tyler J. VanderWeele*, Harvard University 9:00 Partial Identification of the Pure Direct Effect Under Exposure-Induced Confounding Caleb Miles* and Eric Tchetgen Tchetgen*, Harvard University 9:30 Integrative Analysis of Complex Genetic, Genomic and Environmental Data Using Mediation Analysis Xihong Lin*, Harvard University 10:00 Discussant: Bhramar Mukherjee, University of Michigan

* = Presenter n = Student Award Winner Program 103 ENAR2015

64. Motivation and Analysis Strategies for Joint Orchid C (Terrace Level) Modeling of High Dimensional Data in Genetic Association Studies Sponsors: ENAR, ASA Biometrics Section Organizer: Saonli Basu, University of Minnesota Chair: Weihua Guan, University of Minnesota 8:30 Region-Based Test for Gene-Environment Interactions in Longitudinal Studies Zihuai He, Min Zhang*, Seunggeun Lee and Jennifer Smith, University of Michigan Xiuqing Guo, Harbor-UCLA Medical Center Walter Palmas, Columbia University Sharon L.R. Kardia, Ana V. Diez Roux and Bhramar Mukherjee, University of Michigan 8:55 Strategies to Improve the Power of Pathway Analysis in Genetic Association Studies Kai Yu*, Han Zhang, Jianxin Shi and Nilanjan Chatterjee, National Cancer Institute, National Institutes of Health 9:20 A Unified Test for Population-Based Multiple Correlated Phenotype- Genotype Association Analysis Saonli Basu* and Debashree Ray, University of Minnesota 9:45 Modelling Multiple Correlated Genetic Variants Sharon R. Browning*, University of Washington

10:10 Floor Discussion

104 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 65. Recent Developments on Inference for Johnson (3rd Floor) Possibly Time-Dependent Treatment Effects with Survival Data Sponsors: ENAR, ASA Biometrics Section Organizer: Song Yang, National Heart, Lung and Blood Institute, National Institutes of Health Chair: Song Yang, National Heart, Lung and Blood Institute, National Institutes of Health 8:30 Threshold Regression for Lifetime Data Mei-Ling Ting Lee*, University of Maryland, College Park George A. Whitmore, McGill University, Canada 8:55 Hypothesis Testing for an Extended Cox Model with Time-Varying Coefficients Ying Q. Chen*, Fred Hutchinson Cancer Research Center 9:20 Time-Dependent Cut Point Selection for Biomarkers in Censored Survival Data Zhezhen Jin*, Columbia University 9:45 Inference on the Summary Measures of Treatment Effect with Survival Data When There is Possibly Treatment by Time Interaction Song Yang*, National Heart, Lung and Blood Institute, National Institutes of Health

10:10 Floor Discussion

* = Presenter n = Student Award Winner Program 105 66. Journal of Agricultural, Biological and Foster (3rd Floor) Environmental Statistics (JABES) Highlights Sponsors: ENAR, JABES Organizer: Montserrat Fuentes, North Carolina State University Chair: Murali Haran, The Pennsylvania State University 8:30 Limited-Information Modeling of Loggerhead Turtle Population Size John M. Grego* and David B. Hitchcock, University of South Carolina 8:55 Nonlinear Varying-Coefficient Models with Applications to a Photosynthesis Study Damla Senturk*, University of California, Los Angeles Esra Kurum, Medeniyet University Runze Li, The Pennsylvania State University Yang Wang, China Vanke 9:20 Multilevel Latent Gaussian Process Model for Mixed Discrete and Continuous Multivariate Response Data Erin M. Schliep*, Duke University Jennifer A. Hoeting, Colorado State University 9:45 Analysis of Variance of Integro-Differential Equations with Application to Population Dynamics of Cotton Aphids Jianhua Huang*, Texas A&M University

10:10 Floor Discussion

67. Estimation and Inference for High Dimensional Miami Lecture Hall and Data Adaptive Problems (3rd Floor) Sponsor: IMS Organizer: Noah Simon, University of Washington Chair: Michael Wu, Fred Hutchinson Cancer Research Center 8:30 False Discovery Rate Control for Spatial Data Alexandra Chouldechova*, Carnegie Mellon University 8:55 Conditional or Fixed? Different Philosophies in Adaptive Inference Max Grazier-G’sell* and Ryan Tibsharani, Carnegie Mellon Universityo 9:20 Inference for Regression Quantiles After Model Selection Jelena Bradic*, University of California, San Diego Mladen Kolar, University of Chicago 9:45 A Flexible Framework for Sparse Additive Modeling Conditional or Fixed? Different Philosophies in Adaptive Inference Noah Simon*, University of Washington

10:10 Floor Discussion

106 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 68. CONTRIBUTED PAPERS: Merrick I (3rd Floor) Novel Methods for Bioassay Data Sponsor: ENAR Chair: Wen Yu, University of Michigan 8:30 drLumi: Tools for the Analysis of the Multiplex Immunoassays in R Hector Sanz* and John Aponte, Universitat de Barcelona, Spain Jaroslaw Harezlak and Magdalena Murawska, Indiana University Fairbanks School of Public Health, Indianapolis Ruth Aguilar, Gemma Moncunill and Carlota Dobaño, Universitat de Barcelona, Spain Clarissa Valim, Harvard School of Public Health 8:45 A Bayesian Analysis of Bioassay Experiments Luis G. Leon-Novelo*, University of Louisiana at Lafayette Andrew Womack, Indiana University Hongxiao Zhu and Xiaowei Wu, Virginia Polytechnic Institute and State University 9:00 Compound Ranking Based on a New Mathematical Measure of Effectiveness Using Time Course Data from Cell-Based Assays Francisco J. Diaz*, University of Kansas Medical Center 9:15 Nonparametric Classification of Chemicals using Quantitative High Throughput Screening (qHTS) Assays Shuva Gupta*, National Institute of Environmental Health Sciences, National Institutes of Health Soumendra Lahiri, North Carolina State University Shyamal Peddada, National Institute of Environmental Health Sciences, National Institutes of Health 9:30 Robust Bayesian Methods for the Inverse Regression with an Application to Immunoassay Experiments Magdalena Murawska, Indiana University Fairbanks School of Public Health, Indianapolis Hector Sanz, Ruth Aguilar, Gemma Moncunill, Carlota Dobaño and John Aponte, Universitat de Barcelona, Spain Clarissa Valim, Harvard School of Public Health Jaroslaw Harezlak*, Indiana University Fairbanks School of Public Health, Indianapolis 9:45 Estimating the Prevalence of Multiple Diseases via Two-Stage Hierarchical Pooling Md S. Warasi* and Joshua M. Tebbs, University of South Carolina Christopher McMahan, Clemson University 10:00 A Ballooned Beta Regression Model and Its Application to Bioassay Data Min Yi* and Nancy Flournoy, University of Missouri, Columbia

* = Presenter n = Student Award Winner Program 107 69. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Infectious Disease Sponsor: ENAR Chair: Jean-Philippe Fortin, Johns Hopkins Bloomberg School of Public Health 8:30 Viral Genetic Linkage Analysis in the Presence of Missing Data Shelley Han Liu* and Gabriel Erion, Harvard University Vladimir Novitsky and Victor DeGruttola, Harvard School of Public Health 8:45 A Bayesian Approach to Estimating Causal Vaccine Effects on Binary Post-Infection Outcomes Jincheng Zhou*, Minneapolis Medical Research Foundation, University of Minnesota Haitao Chu, University of Minnesota Michael G. Hudgens, University of North Carolina, Chapel Hill M. Elizabeth Halloran, Fred Hutchinson Cancer Research Center and University of Washington 9:00 Exploring Bayesian Latent Class Models as a Potential Statistical Tool to Estimate Sensitivity and Specificity in Presence of an Imperfect or No Gold Standard. Jay Mandrekar*, Mayo Clinic 9:15 Modeling and Inference for Rotavirus Dynamics in Niger Joshua Goldstein*, Murali Haran and Matthew Ferrari, The Pennsylvania State University 9:30 Comparison of Group Testing Algorithms for Case Identification in the Presence of Dilution Effect Dewei Wang*, University of South Carolina Christopher S. McMahan and Colin M. Gallagher, Clemson University 9:45 Cholera Transmission in Ouest Region of Haiti: Dynamic Modeling and Prediction Alexander Kirpich*, Alex Weppelmann, Yang Yang and Ira Longini, University of Florida

10:00 Floor Discussion

108 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 70. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Variable Selection Sponsor ENAR Chair: Angelo Elmi, The George Washington University 8:30 Weak Signal Identification and Inference in Penalized Model Selection Peibei Shi n and Annie Qu, University of Illinois, Urbana-Champaign 8:45 Feature Screening for Time-Varying Coefficient Models Ultra-High Dimensional Longitudinal Data Wanghuan Chu*, Runze Li and Matthew Reimherr, The Pennsylvania State University 9:00 A Regularized Approach for Simultaneous Estimation and Model Selection for Single Index Models Longjie Cheng*, Purdue University Peng Zeng, Auburn University Yu Zhu, Purdue University 9:15 Multi-Step LASSO Haileab Hilafu*, University of Tennessee 9:30 Bayesian Hierarchical Variable Selection Incorporating Multi-Level Structural Information Changgee Chang*, Emory University Yize Zhao, Statistical and Applied Mathematical Sciences Institute Qi Long, Emory University 9:45 Model Selection for Protein Copy Numbers in Populations of Microorganism Burcin Simsek*, Hanna Salman and Satish Iyengar, University of Pittsburgh 10:00 Globally Adaptive Quantile Regression with Ultra-High Dimensional Data Qi Zheng* and Limin Peng, Emory University Xuming He, University of Michigan

* = Presenter n = Student Award Winner Program 109 71. CONTRIBUTED PAPERS: Gautier (3rd Floor) Modeling Health Data with Spatial or Temporal Features Sponsor: ENAR Chair: Guanhua Chen, Vanderbilt University 8:30 Modeling of Correlated Objects with Application to Detection of Metastatic Cancer Using Functional CT Imaging Yuan Wang*, Brian Hobbs, Jianhua Hu and Kim-Anh Do, University of Texas MD Anderson Cancer Center 8:45 A Spatially Varying Coefficient Model with Partially Unknown Proximity Matrix for the Detection of Glaucoma Progression Using Visual Field Data Joshua L. Warren*, Yale School of Public Health Jean-Claude Mwanza, University of North Carolina, Chapel Hill Angelo P. Tanna, Northwestern University Donald L. Budenz, University of North Carolina, Chapel Hill 9:00 Mapping and Measuring the Effect of Privatization on Alcohol and Violence: Does it Really Matter? Loni Philip Tabb* and Tony H. Grubesic, Drexel University 9:15 Modeling Adolescent Health Data Using a Binary Spatial-Temporal Generalized Method of Moments Approach Kimberly Kaufeld*, Statistical and Applied Mathematics Institute and North Carolina State University 9:30 A Piecewise Exponential Survival Model with Change Points for Evaluating the Temporal Association of World Trade Center Exposure with Incident Obstructive Airway Disease Charles B. Hall*, Albert Einstein College of Medicine Xiaoxue Liu, Rachel Zeig-Owens, Mayris P. Webber, Jessica Weakley and Theresa M. Schwartz, Montefiore Medical Center David J. Prezant, Fire Department of the City of New York 9:45 Distributed Lag Models: Examining Associations between the Built Environment and Health Jonggyu Baek*, Brisa N. Sanchez and Veronica J. Berrocal, University of Michigan Emma V. Sanchez-Vaznaugh, San Francisco State University 10:00 Cluster Detection Test in Spatial Scan Statistics: ADHD Application Ahmad Reza Soltani* and Suja Aboukhamseen, Kuwait University

110 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 72. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Advances in Longitudinal Modeling Sponsor: ENAR Chair: Li-An Lin, University of Texas Health Science Center, Houston 8:30 Conditional Modeling of Longitudinal Data with Terminal Event Shengchun Kong*, Purdue University Bin Nan and Jack Kalbfleisch, University of Michigan 8:45 A Marginalized Multilevel Model for Bivariate Longitudinal Binary Data Gul Inan* and Ozlem Ilk Dag, Middle East Technical University, Turkey 9:00 Augmented Beta Rectangular Regression Models: A Bayesian Perspective Jue Wang* and Sheng Luo, University of Texas Health Science Center, Houston 9:15 Rank-Based Regression Models for Longitudinal Data Rui Chen, Tian Chen* and Xin Tu, University of Rochester 9:30 Markov Chains and Continuous Time Multi-State Markov Models Comparisons in Longitudinal Clinical Analysis Lijie Wan*, Richard J. Kryscio and Erin Abner, University of Kentucky 9:45 Applications of Multiple Outputation for the Analysis of Longitudinal Data Subject to Irregular Observation Eleanor M. Pullenayegum*, Hospital for Sick Children 10:00 A Hidden Markov Model Approach to Analyze Longitudinal Ternary Outcome Disease Stage Change Subject to Misclassification Julia Benoit*, University of Houston Wenyaw Chan, University of Texas Health Science Center School of Public Health

* = Presenter n = Student Award Winner Program 111 73. CONTRIBUTED PAPERS: Ibis (3rd Floor) Causal Inference: Average and Mediated Effects Sponsor: ENAR Chair: Jeff Goldsmith, Columbia University 8:30 Instrumental Variable Estimation of the Marginal Average Effect of Treatment on the Treated Lan Liu*, Baoluo Sun, James Robins and Eric Tchetgen Tchetgen, Harvard University 8:45 Within-Subject Designs for Causal Mediation Analysis Yenny Webb-Vargas*, Martin A. Lindquist and Elizabeth A. Stuart, Johns Hopkins Bloomberg School of Public Health Michael E. Sobel, Columbia University 9:00 Mediation Analysis of a Set of Correlated Predictors Using Weighted Quantile Sum Regression Method Bhanu Murthy Evani* and Robert A. Perera, Virginia Commonwealth University Chris Gennings, Icahn School of Medicine at Mount Sinai 9:15 Bayesian Semiparametric Latent Mediation Model Chanmin Kim*, Harvard University Michael J. Daniels, University of Texas, Austin Yisheng Li, University of Texas MD Anderson Cancer Center 9:30 Accounting for Uncertainty in Confounder Selection when Estimating Average Causal Effects in Generalized Linear Models Chi Wang*, University of Kentucky Corwin Matthew Zigler, Harvard School of Public Health Giovanni Parmigiani, Dana-Farber Cancer Institute and Harvard School of Public Health Francesca Dominici, Harvard School of Public Health 9:45 Variable Selection for Estimating Average Causal Effects Douglas Galagate*, U.S. Census Bureau 10:00 Estimating Mediation Effects Under Correlated Errors with an Application to fMRI Yi Zhao n and Xi Luo, Brown University

112 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 74. CONTRIBUTED PAPERS: Stanford (3rd Floor) Variable Selection with High Dimensional Data Sponsor: ENAR Chair: Tanujit Dey, Cleveland Clinic 8:30 Empirical Likelihood Tests for Coefficients in High Dimensional Linear Models Honglang Wang*, Ping-Shou Zhong and Yuehua Cui, Michigan State University 8:45 TPRM: Tensor Partition Regression Models with Applications in Imaging Biomarker Detection Michelle F. Miranda*, Hongtu Zhu and Joseph G. Ibrahim, University of North Carolina, Chapel Hill 9:00 A Boosting-Based Variable Selection Method for Survival Prediction with Genome-Wide Gene Expression Data Yanming Li*, Kevin He, Yi Li and Ji Zhu, University of Michigan 9:15 Statistical Inference in High-Dimensional M-Estimation Hao Chai* and Shuangge Ma, Yale University 9:30 Augmented Weighted Support Vector Machines for Missing Covariates Thomas G. Stewart n, Michael C. Wu and Donglin Zeng, University of North Carolina, Chapel Hill 9:45 Variable Selection on Model Spaces Constrained by Heredity Conditions Andrew Womack, Indiana University, Bloomington Daniel Taylor-Rodriguez*, Statistical and Applied Mathematics Institute and Duke University Claudio Fuentes, Oregon State University

10:00 Floor Discussion ENAR2015

* = Presenter n = Student Award Winner Program 113 TUESDAY, MARCH 17

Lower Promenade 10:15 – 10:30 am — Refreshment Break with Our Exhibitors (Terrace Level)

10:30 am – 12:15 pm 75. Presidential Invited Address Regency Ballroom Sponsor: ENAR (Terrace Level) Organizer/Chair: José Pinheiro, Johnson & Johnson PRD 10:30 Introduction 10:35 Distinguished Student Paper Awards 10:45 Big Data, Big Opportunities, Big Challenges David L. DeMets, Ph.D., Max Halperin Professor of Biostatistics, University of Wisconsin, Madison

1:45 – 3:30 pm 76. Recent Advances in Dynamic Treatment Regimes Ashe Auditorium Sponsors: ENAR, ASA Biometrics Section (3rd Floor) Organizer: Yingqi Zhao, University of Wisconsin, Madison Chair: Yingqi Zhao, University of Wisconsin, Madison 1:45 The LIBERTI Trial for Discovering a Dynamic Treatment Regimen in Burn Scar Repair Jonathan Hibbard and Michael R. Kosorok*, University of North Carolina, Chapel Hill 2:10 From Idealized to Realized: Estimating Dynamic Treatment Regimens from Electronic Medical Records Erica EM Moodie* and David A. Stephens, McGill University 2:35 Adaptive Treatment and Robust Control Robin Henderson*, Newcastle University, UK 3:00 Methods to Increase Efficiency of Estimation When a Test Used to Decide Treatment Has No Direct Effect on the Outcome James M. Robins*, Harvard University

3:25 Floor Discussion

114 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 77. Predictive Models for Precision Medicine Miami Lecture Hall Sponsors: ENAR, ASA Biometrics Section, ASA Mental Health Statistics (3rd Floor) Section, ASA Statistical Programmers Section Organizers: Suchi Saria, Johns Hopkins University and Peter Mueller, University of Texas, Austin Chair: Peter Mueller, University of Texas, Austin 1:45 The Power of Electronic Medical Records as Data-Gathering Tools for the Creation of (a) Longitudinal Personalized Near-Real-Time Predictions of Adverse Outcomes and (b) Data-Driven Advice Systems for Medical Decision-Making David Draper*, University of California, Santa Cruz and eBay Research Labs 2:10 Assessing Illness Severity from Electronic Health Data Suchi Saria*, Johns Hopkins University 2:35 Toward Individualizing Health Care: Statistical Opportunities Yates Coley, Zhenke Wu and Scott L. Zeger*, Johns Hopkins University 3:00 Dancing with Black Swans: A Computational Perspective on Suicide Risk Detection Truyen Tran*, Deakin University and Curtin University, Australia Santu Rana, Wei Luo, Dinh Phung and Svetha Venkatesh, Deakin University, Australia Richard Harvey, Barwon Health, Australia

3:25 Floor Discussion

78. Electronic Health Records: Challenges Orchid C (Terrace Level) and Opportunities Sponsors: ENAR, ASA Biometrics Section, ASA Section on Statistics in Epidemiology Organizer: Paramita Saha Chaudhuri, Duke University Chair: Paramita Saha Chaudhuri, Duke University 1:45 Trials and Tribulations in Trials Using EHR Data Meredith Nahm Zozus*, Duke University 2:10 Statistical Methods for Dealing with Non-Random Observation of Laboratory Data in EHRs Jason A. Roy*, University of Pennsylvania

* = Presenter n = Student Award Winner Program 115 2:35 Extending Bayesian Networks to Estimate Conditional Survival Probability Using Electronic Health Data David M. Vock*, Julian Wolfson, Sunayan Bandyopadhyay, Gediminas Adomavicius and Paul E. Johnson, University of Minnesota Gabriela Vazquez-Benitez and Patrick J. O’Connor, HealthPartners Institute for Education and Research 3:00 Tracking and Predicting Disease from the Electronic Medical Record Joseph Edward Lucas*, Duke University

3:25 Floor Discussion

79. Cost-Effective Study Designs Tuttle (Terrace Level) for Observational Data Sponsor: ENAR Organizer: Patrick Heagerty, University of Washington Chair: Patrick Heagerty, University of Washington 1:45 Design and Analysis of Retrospective Studies for Longitudinal Outcome Data Jonathan S. Schildcrout* and Nathaniel D. Mercaldo, Vanderbilt University School of Medicine 2:15 On the Analysis of Hybrid Designs that Combine Group- and Individual-Level Data Sebastien Haneuse* and Elizabeth Smoot, Harvard School of Public Health 2:45 Test-Dependent Sampling Design and Semi-Parametric Inference for the ROC Curve Haibo Zhou*, University of North Carolina, Chapel Hill Beth Horton, University of Virginia 3:15 Discussant: Paul Rathouz, University of Wisconsin, Madison

116 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 80. Advanced Machine Learning Methods Johnson (3rd Floor) Sponsors: ENAR, ASA Statistical Learning and Data Mining Section Organizer: Peiyong (Annie) Qu, University of Illinois, Champaign-Urbana Chair: Peiyong (Annie) Qu, University of Illinois, Champaign-Urbana 1:45 A New Approach to Variable Selection via Algorithmic Regularization Paths Yue Hu, Rice University Genevera I. Allen*, Rice University and Baylor College of Medicine 2:10 Link Prediction for Partially Observed Networks Yunpeng Zhao, George Mason University Yun-Jhong Wu, Elizaveta Levina and Ji Zhu*, University of Michigan 2:35 Graphical Regression Hsin-Cheng Huang, Academia Sinica, Taiwan Xiaotong Shen* and Wei Pan, University of Minnesota 3:00 Penalized Maximum Likelihood Estimation on a Two-Layered Network George Michailidis*, University of Michigan

3:25 Floor Discussion

81. Statistical Analysis for Deep Sequencing Data in Foster (3rd Floor) Cancer Research: Methods and Applications Sponsor: ENAR Organizer: Li-Xuan Qin, Memorial Sloan Kettering Cancer Center Chair: Yen-Tsung Huang, Brown University 1:45 A Statistical Method for Detecting Differentially Expressed Mutations Based on Next-Generation RNAseq Data Pei Wang*, Icahn School of Medicine at Mount Sinai Rong Fu, University of Washington Ziding Feng, University of Texas MD Anderson Cancer Center 2:10 Accounting for Differential Coverage in Comparing Mutation Prevalence George W. Wright*, National Cancer Institute, National Institutes of Health

* = Presenter n = Student Award Winner Program 117 2:35 Scalable Bayesian Nonparametric Learning for High-Dimensional Lung Cancer Genomics Data Chiyu Gu and Subharup Guha*, University of Missouri Veerabhadran Baladandayuthapani, University of Texas MD Anderson Cancer Center 3:00 Understanding MicroRNA Sequencing Data Distribution Li-Xuan Qin*, Memorial Sloan Kettering Cancer Center Tom Tuschl, Rockefeller University Sam Singer, Memorial Sloan Kettering Cancer Center

3:25 Floor Discussion

82. Spatial and Spatio-Temporal Modeling Merrick II (3rd Floor) Sponsor: IMS Organizer: Jonathan Stroud, The George Washington University Chair: Jonathan Stroud, The George Washington University 1:45 Multivariate Spatial Modeling of Conditional Dependence in Microscale Soil Elemental Composition Data Joseph Guinness*, Montserrat Fuentes, Dean Hesterberg and Matthew Polizzotto, North Carolina State University 2:10 Spatial Local Gradient Models of Biological Invasions Joshua Goldstein, Murali Haran* and Ottar N. Bjornstad, The Pennsylvania State University Andrew M. Liebhold, U.S. Forest Services 2:35 A Generalized Conditionally Autoregressive (CAR) Model Veronica J. Berrocal*, University of Michigan Alan E. Gelfand, Duke University 3:00 Gaussian Process Models for Emulating Spatial Computer Model Output Dave M. Higdon*, Los Alamos National Laboratory and Virginia Tech Mengyang Gu, Duke University

3:15 Floor Discussion

118 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 83. CONTRIBUTED PAPERS: Stanford (3rd Floor) Study Design and Power Sponsor: ENAR Chair: Shelley Han Liu, Harvard University 1:45 Comparison of Risk Estimates Derived from Full Cohort, Sub-Sample, and Nested Case-Cohort Methodologies Kathleen A. Jablonski* and Madeline M. Rice, The George Washington University 2:00 Power Estimation for Ordinal Categorical Data in the Presence of Non Proportional Odds Roy N. Tamura* and Xiang Liu, University of South Florida 2:15 Single Arm Phase II Cancer Survival Trial Designs Jianrong John Wu*, St. Jude Children’s Research Hospitial 2:30 Empirical Determination of Statistical Power and Sample Size for RNA-Seq Studies Milan Bimali*, Jonathan D. Mahnken and Brooke L. Fridley, University of Kansas Medical Center 2:45 Functional Signal-to-Noise Ratio Analysis with Applications in Quantitative Ultrasound Yeonjoo Park* and Douglas G. Simpson, University of Illinois, Urbana-Champaign 3:00 Analysis of a Non-Mortality Outcome in Clinical Trial of a Potentially Lethal Disease Roland A. Matsouaka*, Duke University Rebecca Betensky, Harvard University 3:15 Sample Size Determination Based on Quantile Residual Life Jong Hyeon Jeong*, University of Pittsburgh

* = Presenter n = Student Award Winner Program 119 84. CONTRIBUTED PAPERS: Gautier (3rd Floor) Missing Data Sponsor: ENAR Chair: Shengchun Kong, Purdue University 1:45 A Mixed Effects Model for Incomplete Data with Experiment-Level Abundance-Dependent Missing-Data Mechanism Lin S. Chen and Jiebiao Wang*, University of Chicago Xianlong Wang, Fred Hutchinson Cancer Research Center Pei Wang, Icahn Medical School at Mount Sinai 2:00 Multiple Imputation for General Missing Patterns in the Presence of High-Dimensional Data Yi Deng* and Qi Long, Emory University 2:15 A Mixed-Effects Model for Nonignorable Missing Longitudinal Data Xuan Bi* and Annie Qu, University of Illinois, Urbana-Champaign 2:30 EM Algorithm in Gaussian Copula with Missing Data Wei Ding* and Peter X.K. Song, University of Michigan 2:45 On Identification Issues with Binary Outcomes Missing Not at Random Jiwei Zhao*, University at Buffalo, SUNY 3:00 Kenward-Roger Approximation for Linear Mixed Models with Missing Covariates Akshita Chawla* and Tapabrata Maiti, Michigan State University Samiran Sinha, Texas A&M University 3:15 Nonparametric Sequential Multiple Imputation for Survival Analysis with Missing Covariates Paul Hsu, University of Arizona Mandi Yu*, National Cancer Institute, National Institutes of Health

120 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 85. CONTRIBUTED PAPERS: Ibis (3rd Floor) Innovative Methods for Clustered Data Sponsor: ENAR Chair: Jonggyu Beak, University of Michigan 1:45 Correlation Structure Selection Penalties for Improved Inference with Generalized Estimating Equations Philip M. Westgate* and Woodrow W. Burchett, University of Kentucky 2:00 Handling Negative Correlation and/or Overdispersion in Gaussian and Non-Gaussian Hierarchical Data Geert Molenberghs*, Hasselt University and Leuven University 2:15 Reflecting the Orientation of Teeth in Random Effects Models for Periodontal Outcomes Rong Xia*, Thomas M. Braun and William V. Giannobile, University of Michigan 2:30 Detecting Heterogeneity Based on Effect Size of Response Measures Xin Tong*, University of South Carolina, Columbia 2:45 Statistical Methods for Manifold-Valued Data from Longitudinal Studies Emil A. Cornea*, Hongtu T. Zhu and Joseph G. Ibrahim, University of North Carolina, Chapel Hill 3:00 Analyzing Dependent Data using Empirical Likelihood and Quadratic Inference Function Chih-Da Wu*, University of North Carolina, Chapel Hill Naisyin Wang, University of Michigan 3:15 Fast Estimation of Regression Parameters in a Broken Stick Model for Longitudinal Data Ritabrata Das*, Moulinath Banerjee and Bin Nan, University of Michigan

86. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Biopharmaceutical Applications and Survival Analysis Sponsor: ENAR Chair: Chanmin Kim, Harvard University 1:45 Pseudo-Value Approach for Testing Conditional Residual Lifetime for Dependent Survival and Competing Risks Data Kwang Woo Ahn* and Brent R. Logan, Medical College of Wisconsin 2:00 Fallback Type FDR Controlling Procedures for Testing a Priori Ordered Hypotheses Anjana Grandhi*, Gavin Lynch and Wenge Guo, New Jersey Institute of Technology 2:15 Parametric Inference on Quantile Residual Life Kidane B. Ghebrehawariat*, Ying Ding and Jong-Hyeon Jeong, University of Pittsburgh * = Presenter n = Student Award Winner Program 121 2:30 Study Design Issues in Precision Study for Optical Coherence Tomography Device Haiwen Shi*, U.S. Food and Drug Administration 2:45 Modeling Gap Times between Recurrent Infections after Hematopoietic Cell Transplant Chi Hyun Lee* and Xianghua Luo, University of Minnesota Chiung-Yu Huang, Johns Hopkins University 3:00 Assessing Treatment Effects with Surrogate Survival Outcomes Using an Internal Validation Subsample Jarcy Zee*, Arbor Research Collaborative for Health Sharon X. Xie, University of Pennsylvania 3:15 Inference Concerning the Difference between Two Treatments in Clinical Trials Krishna K. Saha*, Central Connecticut State University

87. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Computational Methods Sponsor: ENAR Chair: Sonja Grill, Technische Universität München 1:45 DNase2TF: An Efficient Algorithm for Footprint Detection Songjoon Baek*, Myong-Hee Sung and Gordon L. Hager, National Cancer Institute, National Institutes of Health 2:00 Spectral Properties of MCMC Algorithms for Bayesian Linear Regression with Generalized Hyperbolic Errors Yeun Ji Jung* and James P. Hobert, University of Florida 2:15 Group Fused Multinomial Regression Brad Price*, University of Miami Charles J. Geyer and Adam J. Rothman, University of Minnesota 2:30 Analysis of MCMC Algorithms for Bayesian Linear Regression with Laplace Errors Hee Min Choi*, University of California, Davis 2:45 On the Use of Cauchy Prior Distributions for Bayesian Binary Regression Joyee Ghosh*, University of Iowa Yingbo Li, Clemson University Robin Mitra, University of Southampton 3:00 Fast, Exact Bootstrap Principal Component Analysis for p > 1 million Aaron Fisher*, Brian Caffo, Brian Schwartz and Vadim Zipunnikov, Johns Hopkins University

3:15 Floor Discussion

122 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner TUESDAY, MARCH 17

Lower Promenade 3:30 – 3:45 pm — Refreshment Break with Our Exhibitors (Terrace Level)

3:45 – 5:30 p.m 88. Biostatistical Methods for Heterogeneous Tuttle (Terrace Level) Genomic Data Sponsor: ENAR Organizer: Wei Sun, University of North Carolina, Chapel Hill Chair: Wei Sun, University of North Carolina, Chapel Hill 3:45 Investigating Tumor Heterogeneity to Identify Etiologically Distinct Sub-Types Colin B. Begg*, Memorial Sloan Kettering Cancer Center 4:10 Statistical Challenges in Cancer Research: Heterogeneity in Functional Imaging and Multi-Dimensional Omics Data Kim-Anh Do*, Thierry Chekouo, Francesco Stingo, Brian Hobbs, Yuan Wang and Jianhua Hu, University of Texas MD Anderson Cancer Center James Doecke, CSIRO, Australian e-Health Research Centre, Brisbane, Australia 4:35 Accounting for Cellular Heterogeneity is Critical in Epigenome-Wide Association Studies Rafael Irizzary*, Harvard University 5:00 Modelling Sources of Variability in Single-Cell Transcriptomics Data Sylvia Richardson*, MRC Biostatistics Unit Cambridge, UK Catalina Vallejos, MRC Biostatistics Unit Cambridge and European Bioinformatics Institute, Hinxton, UK John Marioni, European Bioinformatics Institute, Hinxton, UK

5:25 Floor Discussion

* = Presenter n = Student Award Winner Program 123 89. Innovative Approaches in Competing Orchid C (Terrace Level) Risk Analysis Sponsors: ENAR, ASA Biometrics Section Organizer: Xu Zhang, University of Mississippi Medical Center Chair: Xu Zhang, University of Mississippi Medical Center 3:45 Flexible Modeling of Competing Risks and Cure Rate Qi Jiang and Sanjib Basu*, Northern Illinois University 4:15 Competing Risks Prediction in Two Time Scales Jason Fine*, University of North Carolina, Chapel Hill 4:45 Checking Fine and Gray’s Subdistribution Hazards Model with Cumulative Sums of Residuals Jianing Li, Medical College of Wisconsin Thomas H. Scheike, University of Copenhagen Mei-Jie Zhang*, Medical College of Wisconsin

5:15 Floor Discussion

90. Biomarker Evaluation in Diagnostics Studies Johnson (3rd Floor) with Longitudinal Data Sponsors: ENAR, ASA Biometrics Section, ASA Mental Health Statistics Section, ASA Statistical Programmers Section Organizer: Zheyu Wang, Johns Hopkins University Chair: Zheyu Wang, Johns Hopkins University 3:45 Combination of Longitudinal Biomarkers with Missing Data Danping Liu*, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 4:05 Measures to Evaluate Biomarkers as Predictors of Incident Cases Chao-Kang Jason Liang* and Patrick J. Heagerty, University of Washington 4:25 Prediction Accuracy of Longitudinal Marker Measurement Paramita Saha Chaudhuri*, McGill University Patrick Heagerty, University of Washington 4:45 Estimating Time-Dependent Accuracy Measures for Survival Outcome Under Two-Phase Sampling Designs Dandan Liu*, Vanderbilt University Tianxi Cai, Harvard University Anna Lok, University of Michigan Yingye Zheng, Fred Hutchinson Cancer Research Center

124 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 5:05 Compression of Longitudinal Genomic Biomarkers for Diagnosis Study Le Bao* and Xiaoyue Niu, The Pennsylvania State University Kayee Yeung, University of Washington

5:25 Floor Discussion

91. Solving Clinical Trial Problems by Using Foster (3rd Floor) Novel Designs Sponsors: ENAR, ASA Biopharmaceutical Section Organizer: Anastasia Ivanova, University of North Carolina, Chapel Hill Chair: Gheorge Doros, Boston University 3:45 Some Design Approaches to Address Missing Data Due to Early Discontinuation in Clinical Trials Sonia M. Davis*, University of North Carolina, Chapel Hill 4:15 Introduction to the Sequential Enriched Design Yeh-Fong Chen*, U.S. Food and Drug Administration Roy Tamura, University of South Florida 4:45 Integrity and Efficiency of Enrichment and Adaptive Trial Design and Analysis Options to Enable Accurate and Precise Signal Detection Marc L. de Somer*, PPD 5:15 Discussant: Anastasia Ivanova, University of North Carolina, Chapel Hill

* = Presenter n = Student Award Winner Program 125 92. Ensuring Biostatistical Competence Using Miami Lecture Hall (3rd Floor) Novel Methods Sponsor: ENAR Organizer: Lisa Sullivan, Boston University Chair: Lisa Sullivan, Boston University 3:45 What do Non-Biostatistics Concentrators Need from the Introductory Biostatistics Course? Jacqueline N. Milton*, Boston University 4:15 Creating the Integrated Biostatistics-Epidemiology Core Course: Challenges and Opportunities Melissa D. Begg*, Roger D. Vaughan and Dana March, Columbia University 4:45 Meeting Public Health Career Goals: Course Options in Biostatistics and Epidemiology Marie Diener-West*, Johns Hopkins Bloomberg School of Public Health 5:15 Discussant: Lisa Sullivan, Boston University

93. Methodological Frontiers in the Analysis Ashe Auditorium of Panel Observed Data (3rd Floor) Sponsor: IMS Organizer: Rebecca Hubbard, University of Pennsylvania Chair: Rebecca Hubbard, University of Pennsylvania 3:45 Multi-State Models: A Variety of Uses Vern Farewell*, MRC Biostatistics Unit, Cambridge, UK 4:10 Modeling Cognitive States in the Elderly: The Analysis of Panel Data Using Multi-State Markov and Semi-Markov Processes Richard J. Kryscio*, University of Kentucky 4:35 Second-Order Models of within-Family Association in Censored Disease Onset Times Yujie Zhong* and Richard J. Cook, University of Waterloo 5:00 Computationally Simple State Occupancy Probability Estimates for Multi-State Models Under Panel Observation Andrew Titman*, Lancaster University

5:25 Floor Discussion

126 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 94. CONTRIBUTED PAPERS: Stanford (3rd Floor) Ordinal and Categorical Data Sponsor: ENAR Chair: Haileab Hilafu, University of Tennessee 3:45 Explicit Estimates for Cell Counts and Modeling the Missing Data Indicators in Three-Way Contingency Table by Log-Linear Models Haresh D. Rochani*, Robert L. Vogel, Hani M. Samawi and Daniel F. Linder, Georgia Southern University 4:00 Additive Interactions and the Metabolic Syndrome Matthew J. Gurka* and Baqiyyah N. Conway, West Virginia University Michael E. Andrew and Cecil M. Burchfiel, National Institute for Occupational Safety and Health (NIOSH) Mark D. DeBoer, University of Virginia 4:15 Flexible Link Functions in Nonparametric Binary Regression with Gaussian Process Priors Dan Li* and Xia Wang, University of Cincinnati Lizhen Lin, University of Texas, Austin Dipak K. Dey, University of Connecticut 4:30 Penalized Non-Linear Principal Components Analysis for Ordinal Variables Jan Gertheiss*, Georg August University, Germany 4:45 Covariance Estimation of Proportion for Missing Dichotomous and Ordinal Data in Randomized Longitudinal Clinical Trial Siying Li* and Gary Koch, University of North Carolina, Chapel Hill 5:00 Bayesian Nonparametric Multivariate Ordinal Regression Junshu Bao* and Timothy E. Hanson, University of South Carolina

5:15 Floor Discussion ENAR2015

* = Presenter n = Student Award Winner Program 127 95. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Statistical Genetics Sponsor: ENAR Chair: Chi Wang, University of Kentucky 3:45 Testing Calibration of Risk Models at Extremes of Disease Risk Minsun Song*, National Cancer Institute, National Institutes of Health Peter Kraft and Amit D. Joshi, Harvard School of Public Health Myrto Barrdahl, German Cancer Research Center (DKFZ) Nilanjan Chatterjee, National Cancer Institute, National Institutes of Health 4:00 PLEMT: A Novel Pseudolikelihood Based EM Test for Homogeneity in Generalized Exponential Tilt Mixture Models Chuan Hong n and Yong Chen, University of Texas School of Public Health, Houston Yang Ning, Princeton University Shuang Wang, Columbia University Hao Wu, Emory University Raymond J. Carroll, Texas A&M University 4:15 Regression-Based Methods to Map Quantitative Trait Loci Underlying Function-Valued Phenotypes Il Youp Kwak*, University of Minnesota Karl W. Broman, University of Wisconsin, Madison 4:30 A Framework for Classifying Relationships Using Dense SNP Data and Putative Pedigree Information Zhen Zeng* and Daniel E. Weeks, University of Pittsburgh Wei Chen, Children’s Hospital of Pittsburgh of UPMC Nandita Mukhopadhyay and Eleanor Feingold, University of Pittsburgh 4:45 A Negative Binomial Model-Based Method for Differential Expression Analysis Based on NanoString nCounter Data Hong Wang*, Arnold Stromberg and Chi Wang, University of Kentucky 5:00 Two-Stage Bayesian Regional Fine Mapping of a Quantitative Trait Shelley B. Bull*, University of Toronto and Lunenfeld-Tanenbaum Research Institute Zhijian Chen, Lunenfeld-Tanenbaum Research Institute Radu V. Craiu, University of Toronto 5:15 Optimal Ranking Procedures in Large-Scale Inference: Thresholding Families and the r-value Nicholas C. Henderson* and Michael A. Newton, University of Wisconsin, Madison

128 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 96. CONTRIBUTED PAPERS: Pearson I (3rd Floor) Ecology and Forestry Applications Sponsor: ENAR Chair: Min Wang, Michigan Technological University 3:45 A Statistical Framework for the Genetic Dissection of Evolution Induced by Ecological Interactions Cong Xu*, The Pennsylvania State University Libo Jiang and Meixia Ye, Beijing Forestry University Rongling Wu, The Pennsylvania State University 4:00 Analysis of Variance of Integro-Differential Equations with Application to Population Dynamics of Cotton Aphids Xueying Wang, Washington State University Jiguo Cao*, Simon Fraser University Jianhua Huang, Texas A&M University 4:15 New Insights into the Usefulness of Robust Singular Value Decomposition in Statistical Genetics: Robust AMMI and GGE Models Paulo Canas Rodrigues*, Federal University of Bahia, Brazil Andreia Monteiro and Vanda M. Lourenço, Nova University of Lisbon, Portugal 4:30 A Robust Mixed Linear Model for Heritability Estimation in Plant Studies Vanda M. Lourenço*, Nova University of Lisbon, Portugal Paulo C. Rodrigues, Federal University of Bahia, Brazil Miguel S. Fonseca and Ana M. Pires, University of Lisbon, Portugal 4:45 Cancer Incidence and Superfund Sites in Florida Emily Leary*, University of Missouri Alexander Kirpich, University of Florida

5:00 Floor Discussion

* = Presenter n = Student Award Winner Program 129 97. CONTRIBUTED PAPERS: Pearson II (3rd Floor) Pooled Biospecimens and Diagnostic Biomarkers Sponsor: ENAR Chair: Qingning Zhou, University of Missouri 3:45 Hierarchical Group Testing for Multiple Infections Peijie Hou n and Joshua M. Tebbs, University of South Carolina Christopher R. Bilder, University of Nebraska, Lincoln 4:00 Keeping Risk Calculators Current Donna Pauler Ankerst*, Technical University Munich and University of Health Science Center at San Antonio Andreas Strobl, Technical University Munich 4:15 Evaluation of Multiple Biomarkers in a Two-Stage Group Sequential Design with Early Termination for Futility Nabihah Tayob*, Kim-Anh Do and Ziding Feng, University of Texas MD Anderson Cancer Center 4:30 Flexible and Accessible Semi-Parametric Methods for Analyzing Pooled Biospecimens Emily M. Mitchell*, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health Robert H. Lyles and Amita K. Manatunga, Emory University Enrique F. Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 4:45 Estimating Individualized Diagnostic Rules in the Era of Personalized Medicine Ying Liu n and Yuanjia Wang, Columbia University Chaorui Huang, Cornell University Donglin Zeng, University of North Carolina, Chapel Hill 5:00 Analysis of Unmatched Pooled Case-Control Data Neil J. Perkins*, Emily M. Mitchell and Enrique F. Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 5:15 Estimating TP53 Mutation Carrier Probability in Families with Li-Fraumeni Syndrome Using LFSpro Gang Peng* and Jasmina Bojadzieva, University of Texas MD Anderson Cancer Center Mandy L. Ballinger, Peter MacCallum Cancer Centre, Melbourne, Australia David M. Thomas, The Kinghorn Cancer Centre and Garvan Institute, Sydney, Australia Louise C. Strong and Wenyi Wang, University of Texas MD Anderson Cancer Center

130 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 98. CONTRIBUTED PAPERS: Ibis (3rd Floor) Multiple Testing and Variable Selection Sponsor: ENAR Chair: Lee H Dicker, Rutgers University 3:45 Bayes Factor Approaches for Hypothesis Testing in ANOVA Models Min Wang*, Michigan Technological University 4:00 A Multifunctional Bayesian Procedure for Detecting Copy Number Variations from Sequencing Read Depths Yu-Chung Wei*, U.S. Food and Drug Administration and National Chiao Tung University, Taiwan Guan-Hua Huang, National Chiao Tung University, Taiwan 4:15 Inferring the Global Genetic Architecture of Gene Transcripts from Ultrahigh-Dimensional Molecular Data Kirk Gosik* and Rongling Wu, The Pennsylvania State University 4:30 Statistical Inference for High Dimensional Linear Regression with Linear Constraints and Application to Microbiome Study Pixu Shi*, Anru Zhang and Hongzhe Li, University of Pennsylvania 4:45 Taking into Account Overrepresented Patterns in Gene Expression Analysis Megan Orr* and Ekua Bentil, North Dakota State University 5:00 Bayesian Screening for Group Differences in Methylation Array Data Eric F. Lock*, University of Minnesota 5:15 Incorporating ENCODE Information into SNP-Based Phenotype Prediction Yue-Ming Chen* and Peng Wei, University of Texas School of Public Health, Houston

* = Presenter n = Student Award Winner Program 131 99. CONTRIBUTED PAPERS: Gautier (3rd Floor) Parameter Estimation in Hierarchical and Non-Linear Models Sponsor: ENAR Chair: Jingjing Yin, Georgia Southern University 3:45 A Hierarchical Bayesian Method for Well-Mixed and Two-Zone Models in Industrial Hygiene Xiaoyue Zhao*, Susan Arnold, Dipankar Bandyopadhyay and Gurumurthy Ramachandran, University of Minnesota Sudipto Banerjee, University of California, Los Angeles 4:00 Parameter Estimation: A Bayesian Inference Approach Romarie Morales*, Arizona State University 4:15 Bias and Confidence Interval Correction in Four Parameter Logistic Models Bronlyn Wassink* and Tapabrata Maiti, Michigan State University 4:30 Robust Mixed-Effects Model for Clustered Failure Time Data: Application to Huntington’s Disease Event Measures Tanya P. Garcia*, Texas A&M University Yanyuan Ma, University of South Carolina Yuanjia Wang and Karen Marder, Columbia University 4:45 Stacked Survival Models for Censored Quantile Regression Kyle Rudser*, University of Minnesota Andrew Wey, University of Hawaii John Connett, University of Minnesota 5:00 The CoGaussian Distribution: A Model for Right Skewed Data Govind S. Mudholkar and Ziji Yu*, University of Rochester Saria S. Awadalla, University of Chicago

5:15 Floor Discussion

132 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner WEDNESDAY, MARCH 18

8:30 – 10:15 am 100. New Statistical Methods in the Environmental Miami Lecture Hall Health Sciences (3rd Floor) Sponsors: ENAR, ASA Biometrics Section Organizers: Brisa Sanchez and Peter X.K. Song, University of Michigan Chair: Rong Xia, University of Michigan 8:30 New Statistical Models to Detect Vulnerable Prenatal Window to Carcinogenic Polycyclic Aromatic Hydrocarbons on Fetal Growth Lu Wang*, University of Michigan 8:55 Dimension Reduction for Spatially Misaligned Multivariate Air Pollution Data Adam Szpiro*, University of Washington 9:20 Evaluating Alterations in Regression Coefficients Directed by Toxicant Mixtures Peter X.K. Song*, University of Michigan Shujie Ma, University of California, Riverside

9:45 Floor Discussion

101. Novel Phase II and III Clinical Trial Designs for Pearson (3rd Floor) Cancer Research that Incorporate Biomarkers and Nonstandard Endpoints Sponsor: ENAR Organizer: Sujata Patil, Memorial Sloan Kettering Cancer Center Chair: Nichole Carlson, University of Colorado, Denver 8:30 Novel Phase II and III Designs for Oncology Clinical Trials, with a Focus on Biomarker Validation Daniel J. Sargent*, Mayo Clinic 8:55 Stratified Single Arm Phase 2 Design for Finding a Biomarker Group that Benefits from Treatment Irina Ostrovnaya* and Emily Zabor, Memorial Sloan Kettering Cancer Center

* = Presenter n = Student Award Winner Program 133 9:20 Lung-MAP: A Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer Mary W. Redman*, Fred Hutchinson Cancer Research Center 9:45 Randomized Phase II Design to Study Therapies Designed to Control Growth of Brain Metastases in Cancer Patients Sujata M. Patil*, Memorial Sloan-Kettering Cancer Center

10:10 Floor Discussion

102. Novel Statistical Methods to Decipher Gene Jasmine (Terrace Level) Regulation using Sequence Data Sponsor: ENAR Organizer: Hongyu Zhao, Yale University Chair: Hongyu Zhao, Yale University 8:30 On the Detection of Nonlinear and Interactive Relationships in Genomic Data Bo Jiang and Jun Liu*, Harvard University 8:55 Statistical Analysis of Differential Alternative Splicing Using RNA-Seq Data Mingyao Li*, Yu Hu and Cheng Jia, University of Pennsylvania 9:20 A Case Study of RNA-Seq Data in Breast Cancer Patients Wei Sun*, University of North Carolina, Chapel Hill 9:45 Unit-Free and Robust Detection of Differential Expression from RNA-Seq Data Hui Jiang*, University of Michigan

10:10 Floor Discussion

134 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 103. Flow Cytometry: Data Collection and Foster (3rd Floor) Statistical Analysis Sponsor: ENAR Organizer: Monnie McGee, Southern Methodist University Chair: Monnie McGee, Southern Methodist University 8:30 Flow, Mass and Imaging Cytometry for Single Cell Analysis: A Fertile Field for Biostatistics Research Richard H. Scheuermann*, J. Craig Venter Institute and University of California, San Diego Yu Qian, J. Craig Venter Institute Chiaowen Hsiao, University of Maryland, College Park Monnie McGee, Southern Methodist University 8:55 Computational Identification of Cell Populations from Cytometry Data: Methods, Applications, and Infrastructure Yu Qian* and Hyunsoo Kim, J. Craig Venter Institute Shweta Purawat, University of California, San Diego Rick Stanton, J. Craig Venter Institute Ilkay Altintas, University of California, San Diego Richard H. Scheuermann, J. Craig Venter Institute 9:20 Mapping Cell Populations in Flow Cytometry Data for Cross-Sample Comparison Using the Friedman-Rafsky Test Chiaowen Joyce Hsiao*, University of Maryland, College Park Mengya Liu, Southern Methodist University Rick Stanton, J. Craig Venter Institute Monnie McGee, Southern Methodist University Yu Qian, J. Craig Venter Institute Richard H. Scheuermann, J. Craig Venter Institute and University of California, San Diego 9:45 A Novel Approach to Modeling Immunology Data Derived from Flow Cytometry Jacob A. Turner*, Baylor Institute for Immunology Research 10:10 Discussant: Monnie McGee, Southern Methodist University

104. Statistical Methods in Chronic Kidney Disease Johnson (3rd Floor) Sponsor: ENAR Organizer: Dawei Xie, University of Pennsylvania Chair: Jesse Y. Hsu, University of Pennsylvania 8:30 Joint Modeling of Kidney Function Decline, End Stage Kidney Disease (ESRD), and Death with Special Consideration of Competing Risks Dawei Xie* and Wensheng Guo, University of Pennsylvania Wei Yang, Merrill Lynch Qiang Pan, University of Pennsylvania

* = Presenter n = Student Award Winner Program 135 9:00 Joint Multiple Imputation for Longitudinal Outcomes and Clinical Events which Truncate Longitudinal Follow-Up Bo Hu*, Cleveland Clinic Liang Li, University of Texas MD Anderson Cancer Center Tom Greene, University of Utah 9:30 Modeling the Effect of Blood Pressure on Disease Progression in Chronic Kidney Disease Using Multistate Marginal Structural Models Alisa J. Stephens*, Wei Peter Yang and Marshall M. Joffe, University of Pennsylvania Tom H. Greene, University of Utah 10:00 Dynamic Prediction of Clinical Events Using Longitudinal Biomarkers in a Cohort Study of Chronic Renal Disease Liang Li*, University of Texas MD Anderson Cancer Center

105. Challenging Statistical Issues in Imaging Merrick I (3rd Floor) Sponsors: ENAR, ASA Section on Statistics in Imaging, ASA Statistical Learning and Data Mining Section Organizer: Haipeng Shen and Hongtu Zhu, University of North Carolina, Chapel Hill Chair: Hongtu Zhu, University of North Carolina, Chapel Hill 8:30 Relating Developmental Transcription Factors Based on Drosophila Embryonic Gene Expression Images Siqi Wu*, University of California, Berkeley 8:55 Analysis of Point Pattern Imaging Data using Log Gaussian Cox Processes with Spatially Varying Coefficients Timothy D. Johnson*, University of Michigan Thomas E. Nichols, University of Warwick 9:20 Fiber Direction Estimation in Diffusion MRI Raymond Wong*, Iowa State University Thomas C. M. Lee, Debashis Paul and Jie Peng, University of California, Davis 9:45 FVGWAS: Fast Voxelwise Genome Wide Association Analysis of Large-Scale Imaging Genetic Data Hongtu Zhu* and Meiyang Chen, University of North Carolina, Chapel Hill Thomas Nichols, University of Warwick Chao Huang, Yu Yang and Zhaohua Lu, University of North Carolina, Chapel Hill Qianjing Feng, Southern Medical University Rebecca C. Knickmeyer, University of North Carolina, Chapel Hill

10:10 Floor Discussion

136 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 106. Statistical Methods for Predicting Subgroup Ashe Auditorium (3rd Floor) Level Treatment Response Sponsor: IMS Organizer: Tianxi Cai, Harvard University Chair: Jennifer Anne Sinnot, Harvard School of Public Health 8:30 A Regression Tree Approach to Identifying Subgroups with Differential Treatment Effects Wei-Yin Loh*, University of Wisconsin, Madison 8:55 Feature Elimination for Reinforcement Learning Methods Sayan Dasgupta*, Fred Hutchinson Cancer Research Center Michael R. Kosorok, University of North Carolina, Chapel Hill 9:20 Increasing Efficiency for Estimating Treatment-Biomarker Interactions with Historical Data Jeremy MG Taylor*, Philip S. Boonstra and Bhramar Mukherjee, University of Michiganw 9:45 Adaptive Designs for Developing and Validating Predictive Biomarkers Noah Simon, University of Washington Richard M. Simon*, National Cancer Institute, National Institutes of Health

10:10 Floor Discussion

107. CONTRIBUTED PAPERS: Ibis (3rd Floor) ROC Curves Sponsor: ENAR Chair: Philip M Westgate, University of Kentucky 8:30 Improved Estimation of Diagnostic Cut-Off Point Associated with Youden Index Using Ranked Set Sampling Jingjing Yin*, Hani Samawi, Chen Mo and Daniel Linder, Georgia Southern University 8:45 A Better Confidence Interval for the Sensitivity at a Fixed Level of Specificity for Diagnostic Tests with Continuous Endpoints Guogen Shan*, University of Nevada Las Vegas 9:00 Simpson’s Paradox in the IDI Jonathan Chipman*, Vanderbilt University Danielle Braun, Dana-Farber Cancer Institute 9:15 A Nonparametric Test Based on t-Distribution for Comparing Two Correlated C Indices with Right-Censored Survival Outcome or AUCs with Dichotomous Outcome Le Kang* and Shumei Sun, Virginia Commonwealth University

* = Presenter n = Student Award Winner Program 137 9:30 Latent Mixture Models for Ordered ROC Curves Using the Scale Mixture of Normal Distributions Zhen Chen* and Sungduk Kim, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 9:45 Least Squares ROC Method for Tests with the Absence of the Gold Standard Larry Tang*, George Mason University and National Institutes of Health Clinical Center Minh Huynh, Department of Labor and National Institutes of Health Clinical Center Xuan Che and Elizabeth K. Rasch, Epidemiology and Biostatistics, National Institutes of Health Clinical Center Ao Yuan, Georgetown University

10:00 Floor Discussion

108. CONTRIBUTED PAPERS: Merrick II (3rd Floor) Personalized Medicine and Biomarkers Sponsor: ENAR Chair: Zhenzhen Zhang, University of Michigan 8:30 Using Decision Lists to Construct Interpretable and Parsimonious Treatment Regimes Yichi Zhang n, Eric Laber, Anastasios Tsiatis and Marie Davidian, North Carolina State University 8:45 Synthesizing Genetic Markers for Incorporation into Clinical Risk Prediction Tools Sonja Grill*, Technical University Munich, Germany Donna P. Ankerst, Technical University Munich, Germany and University of Texas Health Science Center at San Antonio 9:00 A PRIM Approach to Predictive-Signature Development for Patient Stratification Gong Chen*, Roche TCRC, Inc. Hua Zhong, New York University School of Medicine Anton Belousov, Roche Diagnostics GmbH Viswanath Devanarayan, AbbVie, Inc. 9:15 On Estimation of Optimal Treatment Regimes for Maximizing t-Year Survival Probability Runchao Jiang n, Wenbin Lu, Rui Song and Marie Davidian, North Carolina State University

138 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 9:30 Evaluation of Novel Biomarkers when Limited by Small Sample Size Bethany J. Wolf*, John Christian Spainhour and Jim C. Oates, Medical University of South Carolina 9:45 Calibrate Variations in Biomarker Measures for Improving Prediction Cheng Zheng*, University of Wisconsin, Milwaukee Yingye Zheng, Fred Hutchinson Cancer Research Center 10:00 Building Small, Robust Gene Signatures to Predict Prognosis Prasad Patil* and Jeffrey T. Leek, Johns Hopkins University

109. CONTRIBUTED PAPERS: Stanford (3rd Floor) Time Series Analysis and Methods Sponsor: ENAR Chair: Haiwen Shi, U.S. Food and Drug Administration 8:30 Robust Portfolio Optimization Under High Dimensional Heavy-Tailed Time Series Huitong Qiu* and Fang Han, Johns Hopkins University Han Liu, Princeton University Brian Caffo, Johns Hopkins University 8:45 Change-Point Detection in EEG Spectra for Informed Frequency Band Selection Anna Louise Schroeder*, London School of Economics Hernando Ombao, University of California, Irvine 9:00 Time Series Analysis for Symbolic-Valued Data S. Yaser Samadi*, Southern Illinois University Lynne Billard, University of Georgia 9:15 High Dimensional State Space Model with L-1 and L-2 Penalties Shaojie Chen* and Joshua Vogelstein, Johns Hopkins University Seonjoo Lee, Columbia University Martin Lindquist and Brian Caffo, Johns Hopkins University 9:30 Autoregressive Models for Spherical Data with Applications in Protein Structure Analysis Daniel Hernandez-Stumpfhauser*, University of North Carolina, Chapel Hill F. Jay Breidt and Mark van der Woerd, Colorado State University 9:45 Modeling Serial Covariance Structure in Semiparametric Linear Mixed-Effects Regression for Longitudinal Data Changming Xia*, University of Rochester Medical Center Hua Liang, The George Washington University Sally W. Thurston, University of Rochester Medical Center

10:00 Floor Discussion

* = Presenter n = Student Award Winner Program 139 WEDNESDAY, MARCH 18

Lower Promenade 10:15 – 10:30 am — Refreshment Break with Our Exhibitors (Terrace Level)

10:30 am – 12:15 pm 110. Incorporating Biological Information in Jasmine (Terrace Level) Statistical Modeling of Genome-Scale Data with Complex Structures Sponsor: ENAR Organizer: Mingyao Li, University of Pennsylvania Chair: Mingyao Li, University of Pennsylvania 10:30 Prioritizing GWAS Results by Integrating Pleiotropy and Annotation Hongyu Zhao*, Yale School of Public Health Dongjun Chung, Medical University of South Carolina Can Yang, Hong Kong Baptist University Cong Li and Qian Wang, Yale University Joel Gelernter, Yale School of Medicine 10:55 Challenges and Solutions for Whole Exome Sequence Analysis for Pedigree and External Control Data Daniel J. Schaid*, Mayo Clinic 11:20 Big Data Methods for Dissecting Variations in High-Throughput Genomic Data Fang Du, Bing He and Hongkai Ji*, Johns Hopkins Bloomberg School of Public Health 11:45 Model-Based Approach for Species Quantification and Differential Abundance Analysis Based on Shotgun Metagenomic Data Hongzhe Li*, University of Pennsylvania

12:10 Floor Discussion

140 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 111. Emerging Issues in Clinical Trials and Ashe Auditorium High Dimensional Data (3rd Floor) Sponsors: ENAR, ASA Biopharmaceutical Section Organizer: Qingxia (Cindy) Chen, Vanderbilt University Chair: Qingxia (Cindy) Chen, Vanderbilt University 10:30 Assessing Covariate Effects with the Monotone Partial Likelihood Using Jeffreys’ Prior in the Cox Model Ming-Hui Chen*, University of Connecticut Mario de Castro, Universidade de Sao Paulo Jing Wu and Elizabeth D. Schifano, University of Connecticut 10:55 Assessing Temporal Agreement between Central and Local Progression-Free Survival Times Donglin Zeng* and Emil Cornea, University of North Carolina, Chapel Hill Jun Dong and Jean Pan, Amgen Inc. Joseph Ibrahim, University of North Carolina, Chapel Hill 11:20 Statistical Design of Non-Inferiority Multiple Region Clinical Trials to Assess Global and Consistent Treatment Effects Guoqing Diao*, George Mason University Donglin Zeng and Joseph G. Ibrahim, University of North Carolina, Chapel Hill Alan Rong, Oliver Lee and Kathy Zhang, Amgen Inc. Qingxia Chen, Vanderbilt University 11:45 Bayesian Shrinkage Methods for High Dimensional Data Joseph G. Ibrahim* and Hongtu Zhu, University of North Carolina, Chapel Hill Zakaria Khondker, Medivation, Inc. Zhaohua Lu, University of North Carolina, Chapel Hill

12:10 Floor Discussion

112. Advances in Repeated Measures and Pearson (3rd Floor) Longitudinal Data Analysis Sponsor: ENAR Organizer: Sanjoy Sinha, Carleton University Chair: Sanjoy Sinha, Carleton University 10:30 Joint Modelling of Different Types of Longitudinal Data with Outliers and Censoring Lang Wu*, University of British Columbia

* = Presenter n = Student Award Winner Program 141 10:55 A Hidden Markov Model for Non-Ignorable Non-Monotone Missing Longitudinal Data for Medical Studies of Quality of Life Kaijun Liao, Hisun Pharmaceuticals USA Qiang Zhang, Radiation Therapy Oncology Group Andrea B. Troxel*, University of Pennsylvania Perelman School of Medicine 11:20 Inverse Weighted Estimating Equations for Repeated Measures in Tranfusion Medicine Richard Cook*, University of Waterloo 11:45 Joint Modelling of Nonignorable Missing Longitudinal Outcomes and Time-to-Event Data Sanjoy Sinha*, Carleton University

12:10 Floor Discussion

113. Advances in Modeling Zero-Inflated Data Johnson (3rd Floor) Sponsors: ENAR, ASA Mental Health Statistics Section Organizer: Brian Neelon, Duke University Chair: James O’Malley, Dartmouth University 10:30 Bayesian Two-Part Spatial Models for Semicontinuous Data Brian Neelon*, Duke University Li Zhu, University of Pittsburgh Sara Benjamin, Duke University 10:55 Zero-Inflated Frailty Model for Recurrent Event Data Lei Liu*, Northwestern University Xuelin Huang, University of Texas MD Anderson Cancer Center Alex Yaroshinsky, Vital Systems Inc. 11:20 Two-Part Models for Rolling Admission Group Therapy Data Lane F. Burgette* and Susan M. Paddock, RAND Corporation 11:45 A Marginalized Two-Part Model for Semicontinuous Data Valerie A. Smith*, Center for Health Services Research in Primary Care, Durham VAMC and University of North Carolina, Chapel Hill John S. Preisser, University of North Carolina, Chapel Hill Brian Neelon, Duke University Matthew L. Maciejewski, Center for Health Services Research in Primary Care, Durham VAMC

12:10 Floor Discussion

142 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 114. New Developments in Missing Data Analysis: Merrick II (3rd Floor) From Theory to Practice Sponsors: ENAR, ASA Survey Research and Methodology Section Organizer: Lihong Qi, University of California, Davis Chair: Yi Li, University of Michigan 10:30 Competing Risks Regression with Missing Data in the Prognostic Factors Federico Ambrogi*, University of Milan Thomas H. Scheike, University of Copenhagen 10:55 Comparison of Multiple Imputation via Chained Equations and General Location Model for Accelerated Failure Time Models with Missing Covariates Lihong Qi*, University of California, Davis Yulei He, Centers for Disease Control and Prevention Rongqi Chen, Ying-Fang Wang and Xiaowei Yang, University of California, Davis 11:20 The Effect of Data Clustering on the Multiple Imputation Variance Estimator Yulei He*, Iris Shimizu, Susan Schappert, Nathaniel Schenker, Vladislav Beresovsky, Diba Khan and Roberto Valverde, Centers for Disease Control and Prevention 11:45 Fractional Hot Deck Imputation for Multivariate Missing Data in Survey Sampling Jae kwang Kim* and Wayne A. Fuller, Iowa State University

12:10 Floor Discussion

115. Environmental Methods with Deterministic Foster (3rd Floor) and Stochastic Components Sponsor: ENAR Organizer: Ed Boone, Virginia Commonwealth University Chair: Edward L. Boone, Virginia Commonwealth University 10:30 High Resolution Nonstationary Random Field Simulation William Kleiber*, University of Colorado, Boulder 10:50 Estimating Parameters in Delay Differential Equation Models Liangliang Wang* and Jiguo Cao, Simon Fraser University 11:10 Zero-Inflated Spatial Temporal Models for Exploring Trend in Comandra Blister Rust Infection in Lodge Pole Pine Trees Cindy Feng*, University of Saskatchewan

* = Presenter n = Student Award Winner Program 143 11:30 A Spatio-Temporal Approach to Modeling Spatial Covariance Ephraim M. Hanks*, The Pennsylvania State University 11:50 Incorporating Covariates in Deterministic Environmental Models Edward L. Boone*, Virginia Commonwealth University Ben Stewart-Koster, Australian Rivers Institute at Griffith University

12:10 Floor Discussion

116. Bayesian and Non-Parametric Bayesian Miami Lecture Hall (3rd Floor) Approaches to Causal Inference Sponsor: IMS Organizer: Peter Mueller, University of Texas, Austin Chair: Peter Mueller, University of Texas, Austin 10:30 A Bayesian Nonparametric Causal Model for Regression Discontinuity Designs George Karabatsos*, University of Illinois, Chicago Stephen G. Walker, University of Texas, Austin 10:55 Evaluating the Effect of University Grants on Student Dropout: Evidence from a Regression Discontinuity Design Using Bayesian Principal Stratification Analysis Fan Li*, Duke University Alessandra Mattei and Fabrizia Mealli, University of Florence 11:20 Bayesian Nonparametric Estimation for Dynamic Treatment Regimes with Sequential Transition Times Yanxun Xu* and Peter Mueller, University of Texas, Austin Abdus S. Wahed, University of Pittsburgh Peter F. Thall, University of Texas MD Anderson Cancer Center 11:45 A Framework for Bayesian Nonparametric Inference for Causal Effects of Mediation Chanmin Kim, Harvard University Michael J. Daniels*, University of Texas, Austin Jason Roy, University of Pennsylvania

12:10 Floor Discussion

144 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 117. Design of Multiregional Clinical Trials: Merrick I (3rd Floor) Theory and Practice Sponsor: ENAR Organizer: Gordon Lan, Janssen Research & Development Chair: Gordon Lan, Janssen Research & Development 10:30 Random Effects Models for Multiregional Clinical Trial Design and Analysis Gordon Lan*, Janssen Research & Development 11:15 Consistency of Treatment Effect in Multiregional Clinical Trials Joshua Chen*, Sanofi Pasteur 11:50 Discussant: Fei Chen, Janssen R&D, Johnson & Johnson

12:05 Floor Discussion

118. CONTRIBUTED PAPERS: Ibis (3rd Floor) Multivariate Survival Analysis Sponsor: ENAR Chair: Minsun Song, National Cancer Institute, National Institutes of Health 10:30 A Sieve Semiparametric Maximum Likelihood Approach for Regression Analysis of Bivariate Interval-Censored Failure Time Data Qingning Zhou*, University of Missouri Tao Hu, Capital Normal University Jianguo Sun, University of Missouri 10:45 Methods for Contrasting Gap Time Hazard Functions Xu Shu* and Douglas E. Schaubel, University of Michigan 11:00 Using Full Cohort Information to Improve the Effciency of Multivariate Marginal Hazard Model for Case-Cohort Studies Hongtao Zhang*, Jianwen Cai, Haibo Zhou and David Couper, University of North Carolina, Chapel Hill 11:15 Marginal Models for Restricted Mean Survival with Clustered Time to Event Data Using Pseudo-Values Brent R. Logan* and Kwang Woo Ahn, Medical College of Wisconsin 11:30 Semi-Parametric Modeling of Bivariate Recurrent Events Jing Yang* and Limin Peng, Emory University

* = Presenter n = Student Award Winner Program 145 11:45 Analysis of a Composite Endpoint Under Different Censoring Schemes for Component Events via Multiple Imputation Yuqi Chen*, University of California, Santa Barbara Chunlei Ke, Amgen Inc. Jianming Wang, Celgene Corporation 12:00 Quantile Regression for Survival Data with Delayed Entry Boqin Sun* and Jing Qian, University of Massachusetts, Amherst

119. CONTRIBUTED PAPERS: Stanford (3rd Floor) Constrained Inference Sponsor: ENAR Chair: Emily Leary, University of Missouri 10:30 Order Statistics from Lindley Distribution and their Applications Khalaf S. Sultan* and Wafaa S. AL-Thubyani, College of Science King Saud University, Saudi Arabia 10:45 CLME: A Tool for Inference in Linear Mixed Effects Models Under Inequality Constraints Casey M. Jelsema* and Shyamal D. Peddada, National Institute of Environmental Health Sciences, National Institutes of Health 11:00 Order-Constrained Bayesian Nonparametric Modeling of Correlated Three-Way ROC Surfaces Beomseuk Hwang* and Zhen Chen, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health 11:15 Partial Likelihood Estimation of Isotonic Proportional Hazards Models Yunro Chung*, Anastasia Ivanova, Michael Hudgens and Jason Fine, University of North Carolina, Chapel Hill 11:30 Nonparametric Tests of Uniform Stochastic Ordering Chuan-Fa Tang*, Joshua M. Tebbs and Dewei Wang, University of South Carolina 11:45 Covariate Balanced Restricted Randomization: Optimal Designs, Exact Tests, and Asymptotic Properties Jingjing Zou* and Jose R. Zubizarreta, Columbia University

12:00 Floor Discussion

146 ENAR 2015 | Spring Meeting | March 15–18 * = Presenter n = Student Award Winner 120. CONTRIBUTED PAPERS: Gautier (3rd Floor) Nonparametric Methods Sponsor: ENAR Chair: Nabihah Tayob, University of Texas MD Anderson Cancer Center 10:30 Nonparametric and Semiparametric Estimation in Multiple Covariates Richard Charnigo*, University of Kentucky Limin Feng, Intel Corporation Cidambi Srinivasan, University of Kentucky 10:45 Nonparametric Empirical Bayes via Maximum Likelihood for High-Dimensional Classification Lee H. Dicker, Rutgers University Sihai D. Zhao, University of Illinois, Urbana-Champaign Long Feng*, Rutgers University 11:00 Nonparametric Inference for an Inverse-Probability-Weighted Estimator with Doubly Truncated Data Xu Zhang*, University of Mississippi Medical Center 11:15 A Test For Directional Departure From Loewe Additivity Mingyu Xi*, University of Maryland, Baltimore County 11:30 Estimation and Confidence Bands for Nonparametric Regression with Functional Responses and Multiple Scalar Covariates Andrada E. Ivanescu*, Montclair State University 11:45 Nonparameteric Bayesian Analysis of The 2 Sample Problem with Censoring Kan Shang* and Cavan Sheerin Reilly, University of Minnesota ENAR 2015

Index

160 ENAR 2015 | Spring Meeting | March 15–18 ENARHyatt Regency Miami 2015 3D Meeting Space Layout

Floor Plan

Hyatt Regency Miami Lobby

Program 161 Statistics Recent releases of SAS/STAT® software provide exciting new capabilities. Highlights include:

SAS/STAT 13.2 Weighted GEE methods. Deal with drop-outs in longitudinal studies with a method that produces unbiased estimates under the missing-at-random (MAR) assumption.

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Proportional hazards regression models for interval-censored data. Apply Cox regression models when you have interval-censored data.

Nested multilevel nonlinear mixed models. Fit hierarchical models often used in the analysis of pharmacokinetics data.

SAS/STAT 13.1 Sensitivity analysis for multiple imputation. Assess sensitivity of multiple imputation to the missing at random assumption with pattern-mixture models.

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Bayesian choice models. Use Bayesian discrete choice analysis to model consumer decisions in choosing products or selecting from multiple alternatives.

Competing risk models. Analyze time-to-event data with competing risks using the method of Fine and Gray (1999).

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